Digital x-ray systems flood market as vendors hope for purchasing wave

The arrival of new digital x-ray technology was evident at the December RSNA meeting as many vendors displayed digital radiography systems as commercial products for the first time. Established multimodality vendors showcased digital detectors as part of integrated x-ray systems, while smaller companies came out of the woodwork with new solutions designed to bring radiology’s oldest modality into the digital age.

Digital x-ray may be ready to emerge from its development phase, but now comes the hard part: persuading hospitals and clinicians to convert to digital. Some market watchers are concerned that the high price tags of the new systems will limit sales. Vendors claim that digital x-ray will enable radiology departments to operate more efficiently with less equipment, but the fact remains that the new digital systems in some cases cost three times as much as the analog units they are designed to replace.

There may also be some market confusion caused by the plethora of different technologies being used to digitize x-rays. The new approaches include amorphous silicon, amorphous selenium, storage phosphor, and CCDs. Even newer digitization methods such as complementary metal-oxide semiconductors (CMOS) are beginning to appear. To add to the confusion, vendors are trying to differentiate their products by highlighting features such as detective quantum efficiency (DQE), modulation transfer function (MTF), direct versus indirect conversion, and image stitching (or lack of same).

Ultimately, the success of digital x-ray will depend less on such arcane technical characteristics and more on whether hospitals and physicians’ offices can wring enough productivity from the new systems to justify their higher prices. The next few years should prove critical as companies wait to see whether their investments in digital technology are rewarded with increased equipment sales.

Advanced Instrument Development

• Exhibiting at its second RSNA meeting, AID of Melrose Park, IL, displayed the CCD-based digital x-ray technology it imports from Finnish technology firm Imix. The detector is used in digital radiography systems sold by Trex, and AID is interested in securing additional OEM partnerships for territories outside the U.S., AID executives said.
• AID’s technology is based on a single large 16 x 16-inch CCD, which eliminates potential problems with matching images from multiple CCDs. The detectors have a pixel size of 200 microns, which translates into resolution of 2.5 lp/mm with 16-bit acquisition, resulting in good dynamic range.

Agfa Medical

• Agfa highlighted ADC Solo, a single-plate CR reader with a price point of around $100,000. Designed as an entry-level CR product, ADC Solo has a throughput of 70 plates per hour and is appropriate for clinics, trauma centers, and ICU environments, according to the firm. It could also function as a backup unit for digital radiography systems or higher end CR readers, according to the Ridgefield Park, NJ-based firm.

Canon USA

• In a case of fortuitous timing, Canon of Lake Success, NY, received FDA clearance for its Digital Radiography System just prior to the conference (SCAN 11/25/98). Canon plans to market the system for digital chest applications, primarily as a retrofit device. The company believes that most hospitals will want to upgrade to digital via the retrofit route rather by acquiring a completely new system.
• Canon has priced Digital Radiography System retrofits at $240,000, much less than the $350,000 to $400,000 price of most new digital x-ray systems. Canon is selling the units through dealers, said Neo Imai, sales support manager.
• Based on amorphous silicon technology, Digital Radiography System has a 17 x 17-inch active area and a 160-micron pixel size, resulting in resolution of 3.1 lp/mm with 12-bit contrast.
• In the future, Canon plans to offer a table-based x-ray system, with availability in early 1999. A 510(k) application is pending for a bucky-style sensor, and Canon also hopes to develop a cassette-based detector for applications such as remote imaging.

Cares Built

• While most digital detector developers focus on technology using CR, amorphous silicon or selenium, or CCDs, Cares Built has taken a different tack. This Keyport, NJ, company has based its digital method on CMOS, a relatively new digitization technology. Cares Built claims that its CMOS detectors have image quality about twice that of comparable systems, with 7 lp/mm resolution in a 7K x 7K matrix and 100 db of dynamic range.
• Cares Built’s detector, called Clarity 7000, is designed to retrofit into bucky-style x-ray systems. Thanks to CMOS technology, the detector is thinner than other digital detectors on the market, making it easier to retrofit installed systems, according to Marc Regan, sales manager.
• The company hopes to have 510(k) clearance for Clarity 7000 in the first quarter of 1999, and will sell the detectors through its dealer network. Cares Built also plans to offer the detectors as part of new integrated x-ray systems, Regan said.

Del Medical Systems

• Del of Valhalla, NY, finalized its acquisition of the radiography/fluoroscopy assets of Acoma Medical Imaging of Wheeling, IL, just prior to the RSNA conference (SCAN 12/16/98). The deal expands Del’s product line and makes the company a more attractive partner to OEMs, according to president and CEO Leonard Trugman.
• The company also adopted a new identity, Del Medical Systems Group, to include its Dynarad and Gendex operations. Dave Engel has been named president of the group.

Deus Technologies

• A new computer-aided detection system for lung cancer applications was showcased as a work-in-progress by Deus, a Rockville, MD, firm that made its RSNA debut at the 1998 meeting. The RapidScreen lung cancer detection system uses CAD algorithms, developed by the University of Chicago and other locations, that Deus has licensed.
• RapidScreen features a built-in x-ray film scanner to digitize chest films, but the system is capable of working with any digital image, according to the company. The system uses technologies such as neural network computing and pattern recognition to detect and flag suspicious lung nodules. Deus is in the process of filing a premarket approval (PMA) application for RapidScreen.

DpiX

• This Palo Alto, CA, company made its RSNA debut at the December meeting, reporting that several manufacturers are evaluating the company’s FlashScan 30 digital detector for use as a retrofit to existing radiography systems. Some firms are also interested in using it in magnification digital mammography applications, said Jean-Pierre Georges, vice president of sales and marketing.
• DpiX also displayed a work-in-progress amorphous silicon detector array that may have applications in high-resolution digital radiography as well as digital mammography, Georges said. The 30 x 40-cm array incorporates a 97-micron pixel size, and comprises over 12 million pixels, according to dpiX.

Eastman Kodak

• Kodak introduced Computed Radiography System 400 Plus, which adds new features such as image processing software suitable for both CR and digital radiography applications. The software automates image processing and enhancement, and also improves image quality, according to the Rochester, NY-based firm.
• Research continues on the company’s digital radiography system. Unlike the 1997 RSNA meeting, Kodak did not demonstrate images generated from the system. The company is continuing to evaluate the technology, but no commercialization plans are in place at this time, said Michael Moehring, product line manager for CR and DR.

Eliav Medical Imaging Systems

• This Israeli firm took advantage of its first RSNA meeting to demonstrate PortPro, a digital radiography system used in radiation therapy applications to help position patients before treatment begins. PortPro is based on CCD detectors, according to Reuven Levinson, president of the Haifa company. Although PortPro’s resolution of 0.35 lp/mm isn’t suitable for diagnostic applications, the company is planning to develop a diagnostic version of the system.

Fischer Imaging

• On display in Fischer’s booth were the digital x-ray systems it is manufacturing in collaboration with partner Sterling Diagnostic Imaging. Fischer of Denver is integrating Sterling’s DirectRay digital detectors with its own x-ray equipment, and both companies have rights to sell the units.
• Two of Fischer’s systems include a digital chest product and a digital version of its Traumex unit. The company also displayed a digital isocentric C-arm called Traumex-C, and a cantilevered trauma table called Tangent IV. All the systems have FDA clearance, with the exception of Traumex-C, according to Anthony DeCarolis, vice president of sales and marketing. Like Sterling, Fischer has just begun production shipments of the digital systems.
• As a work-in-progress, Fischer displayed a DirectRay digital detector table integrated into an x-ray table.

Fuji Medical Systems USA

• Fuji of Stamford, CT, displayed its FCR 5000 series of readers as commercial products after introducing them as works-in-progress at the 1997 meeting. The line’s flagship reader, FCR 5000, is a high-speed unit designed to handle the output of three busy radiology rooms, with a throughput of up to 115 imaging plates an hour.
• Fuji expanded the line at the 1998 conference, introducing FCR 5000R-ID, FCR 5000R-Console, and FCR 5501 models. FCR 5000R-ID is a single-plate reader with a throughput of 80 plates per hour, and includes a remote patient identification terminal to support two or more mid-volume rooms. FCR 5000R-Console has the same throughput as FCR 5000-ID, but has an integrated ID console and high-resolution imaging capabilities and is designed to be sited within an x-ray room. FCR 5501 is an upright reader that offers a 17 x 17-inch imaging area and a 120 plate/hour processing speed.

GE Medical Systems

• Revolution is GE’s product name for the amorphous silicon flat-panel digital detectors it has developed through a collaboration with EG&G Amorphous Silicon of Santa Clara, CA. GE received clearance for the first digital system, a digital chest x-ray unit called Revolution XQi, in October (SCAN 11/11/98).
• The Milwaukee company is taking a measured approach to rolling out the units, according to Jeff Irish, general manager of global x-ray. The first clinical units are being shipped now, with pilot systems over the next six months. Full commercial production will follow, he said.
• GE highlighted Revolution’s high detective quantum efficiency (DQE), at 65% to 70%, and its low-noise electronics, which support advanced applications like CAD software. Revolution features a detector made from a single plate of glass with a 17 x 17-inch active area, with a pixel size of 200 microns.
• The price range of a Revolution XQi system will be $300,000 to $500,000. The low end of that range is for a basic system with x-ray tube, generator, detector, and acquisition workstation. More expensive models could include additional components like high-resolution review workstations, archives, and other PACS components.

Hitachi Medical Corporation of America

• New x-ray products were a highlight in Hitachi’s booth. The Twinsburg, OH, company is planning to become more active in the U.S. x-ray market, and has hired former SMV veteran Bill Bishop to help spearhead the effort.
• VersiFlex is a new tilting C-arm that Hitachi displayed in its booth. The floor-mounted unit is capable of vascular and R/F work and will begin shipping in mid-1999, Bishop said.
• SX-VA30 is a catheterization lab that will begin shipping in the second quarter, while SF-VA100 is Hitachi’s unique rotational 3-D angiography system that has appeared at past meetings. Shipments of that product should begin in late 1999.

InfiMed

• InfiMed plans to target the retrofit market for digital radiography by taking advantage of its experience in providing digital retrofits for R/F rooms. The Liverpool, NY, company’s StingRay detectors are based on Trixell amorphous silicon flat panels, with InfiMed’s own image processing techniques. InfiMed plans to offer StingRay detectors in two configurations: as upgrades for conventional radiography rooms and as upgrades for the company’s GoldOne digital R/F customers. Adding StingRay to a GoldOne lab will give the lab the added ability to conduct digital radiography studies. The company plans to submit a 510(k) for StingRay in the first quarter. Farther down the road, InfiMed is developing Xicon detectors for flat-panel digital fluoroscopy studies.

Instrumentarium Imaging

• A mobile C-arm with a flat-panel digital fluoroscopy detector manufactured by Varian Associates was showcased in Instrumentarium’s booth. The Milwaukee company believes that flat-panel technology can provide better resolution than an image intensifier, and can also save space. Clinical tests of the digital C-arm should begin in the spring.

Konica Medical

• The company’s Regius chest and abdomen computed radiography reader took center stage at the booth this year. Shown at the 1997 meeting as a work-in-progress and cleared in June (SCAN 7/22/98), Regius is now commercially available and is scheduled for installation at sites within the next 30 to 60 days, according to the Wayne, NJ-based firm.

Lumisys

• Lumisys of Sunnyvale, CA, formally unveiled ACR-2000, its low-cost computed radiography reader. About 20 demonstration units have been shipped, with the first full commercial shipments to begin this month, said president and CEO Philip Berman. Brit Systems, DR Systems, and Picker International have signed on as OEMs for the offering. Agfa also displayed ACR-2000 in its booth. In addition, 10 domestic distributors and 12 international distributors will be selling ACR-2000.

OEC Medical Systems

• A major draw in the booth of this Salt Lake City-based C-arm developer was a new head-mounted display that enables clinicians to see images on a visor just above their eyes, rather than on ceiling-mounted monitors. This eliminates continual head tilting. The display is voice-controlled and works in conjunction with OEC’s fixed-room UroView and high-end Series 9600 C-arms.
• Also new were OEC’s Series 7700 and Compact 7700 C-arms, as well as a digital version of Series 9600 with a CCD receptor.

Oldelft

• This Dutch company highlighted the AmberScan upgrade for its Digidelca-C digital chest imaging system, a CCD-based device that received clearance in April (SCAN 6/10/98). AmberScan improves the unit by preprocessing Digidelca’s x-ray beam before it hits the patient, adjusting the x-ray dose to match the type of tissue being scanned.
• Oldelft has begun sales of Digidelca-C in the U.S. through its distributor network and has sold eight units worldwide. The list price of Digidelca-C with AmberScan is $300,000.

Philips Medical Systems

• Philips’ efforts in flat-panel digital x-ray culminated in November, when the company received FDA clearance for Digital Diagnost, a bucky-style x-ray system based on Philips’ Bucky TH conventional x-ray table retrofitted with a Trixell Pixium amorphous silicon digital detector. The first system has been installed at the University of Bremen in Germany, and clinical results from the system were presented at the conference. Production units will begin shipping this summer, at a list price that is “competitive” with other digital x-ray systems.
• New conventional x-ray systems include DuoDiagnost, a multipurpose radiography and radiography/fluoroscopy system, and OmniDiagnost, a remote multipurpose R/F table. Both feature new advances in ergonomic design. On DuoDiagnost, a geometry that Philips calls a free-arm segment incorporates both a bucky and remote-controlled R/F into one system, while OmniDiagnost features a design in which the table is fixed and the scanning column moves around it.
• As a work-in-progress, Philips highlighted its development of Integris 3D-RA, an advanced 3-D rotational angiography workstation that provides reconstructed 3-D images of vascular morphology. Philips is designing the workstation to make its initial 3-D reconstruction within six minutes of acquisition (including image transfer time to the workstation).
• BV300 is a new series of mobile mini-C-arms for use in surgical environments. The units can be configured with 9-inch or 12-inch image intensifiers.

Picker International

• Clearance for Picker’s Live-X flat-panel fluoroscopy technology was the big news at this Cleveland company’s booth. Picker touted the fact that the clearance was the first to be received for a flat-panel fluoro system. The vendor highlighted the initial application for the detectors as part of its Venue FACTS interventional CT suite. Live-X is based on Varian’s VIP-9 amorphous silicon sensor.
• On the conventional side, RadView is a new line of radiography tables that come in two versions: either ceiling-suspended or integrated-tube-column configurations. The company emphasized the 650-pound patient limit of the table. RadView was designed to incorporate flat-panel detectors, and Picker displayed a work-in-progress workstation for viewing digital images. Picker has shipped 130 RadView units.
• FluoroView is a remote R/F version of RadView, which was displayed in an all-digital version with Picker’s 12-bit D-Max CCD digitization package.

Rogan Medical Systems

• Rogan showed a flat-panel digital radiography detector as a work-in-progress. Like the Cares Built unit, Rogan’s detector is based on CMOS technology and yields a 40-micron pixel size and a 17 x 17-inch active image area. The company will submit a 510(k) application to the FDA soon, said president Mark Schwartz. When available, Pewaukee, WI-based Rogan will sell the detector through a distribution network as a retrofit or as part of a new digital radiography system.

Shimadzu Medical Systems

• This Torrance, CA, company highlighted technologies that are now commercially shipping after being shown as works-in-progress at previous RSNA meetings. Digitex Pro has begun shipping as a digital system for both R/F and angio units. The first Digitex Pro installations are for Shimadzu’s Cvision C-arm table unit.
• New enhancements for the MH-100 ceiling-suspended angiography system include up to 30/second of rotation at 30 fps in 1024 mode for rotation digital subtraction angiography. The company’s YSF-120D features Digitex Pro in place of the spot-film device, according to Don Karle, director of sales and marketing.
• Although Shimadzu did not exhibit digital x-ray detectors in its booth, the company acknowledged that it has a flat-panel program under way in Japan. Shimadzu hopes to develop a combination radiography and R/F detector that can be shown as a work-in-progress at the 1999 RSNA show.

Siemens Medical Systems

• Siemens displayed flat-panel digital detectors on two x-ray products: Thorax FD, a chest unit, and Multix FD, a table-based bucky system. Both feature the Pixium 4600 detectors developed by Trixell, with 17 x 17-inch active areas and 143-micron pixel sizes. Siemens is expecting 510(k) clearance for the systems in early 1999 and plans to begin shipments in the second half of the year, according to Kurt Reiff, product manager for radiographic tables. Thorax FD is priced at $350,000 and Multix FD between $400,000 and $450,000.
• Sireskop CX Compact is a new mid-tier R/F system with film and digital capability.

Sterling Diagnostic Imaging

• The Greenville, SC, company highlighted the progress it has made in bringing its DirectRay amorphous selenium digital detector technology to market since receiving clearance for the systems in July (SCAN 7/22/98). As of December, three iiRad DR 1000C digital chest systems had been installed, and Sterling held a press conference at the RSNA meeting to allow clinicians to discuss their experiences with the units.
• Sterling had received 31 orders for DR systems as of the RSNA meeting, with 19 of them for DR 1000C systems and 12 for DR 1000, a multipurpose system. Sterling has also successfully installed a DR detector as a retrofit to a GE Monitrol x-ray system at Brooke Army Medical Center in San Antonio, according to Rod Wolford, Sterling CEO. Sterling is in discussion with the Army about retrofitting more Monitrol systems.
• Sterling’s flat-panel supply woes appear to be clearing up. The company has secured the remaining supply of thin-film-transistor arrays from beleaguered supplier Optical Imaging Systems (SCAN 11/11/98) and is in discussion with two other companies for TFT arrays. Shipments from those firms should occur in the second or third quarter.

Swissray International

• A new product name for Swissray’s AddOn-Multi-System was in the cards, with Swissray renaming its multipurpose digital x-ray unit ddR Multi-System. The new name reflects the integrated nature of the product and its ability to bring a radiology department into the digital age, rather than an add-on module to be offered as a retrofit.
• Swissray plans to position ddR Multi-System against other digital x-ray products flooding the market by emphasizing its functionality. Most of the new digital systems are targeted at chest applications, whereas ddR Multi-System is appropriate for extremity work and other applications, according to Ueli Laupper, CEO of the New York City company.
• About 12 to 14 ddR Multi-Systems were scheduled to be shipped by the end of 1998, and Swissray hopes to have 80 to 100 installed by the end of 1999. The company is close to having its U.S. distribution network in place, Laupper said.
• As works-in-progress, Swissray discussed digital fluoroscopic applications with its CCD-based detectors, which it hopes to offer as an upgrade in the next 12 months. A digital stereo option using 3-D eyewear was also highlighted.

Thomson Tubes Electroniques

• Trixell’s Pixium 4600 flat-panel digital detectors were displayed in Thomson’s booth. The detectors also appeared as part of integrated x-ray systems in the booths of a number of companies, ranging from large OEMs like Siemens and Philips to smaller firms like InfiMed.

Toshiba America Medical Systems

• Symphony is Toshiba’s term for an equipment package that enables radiology departments to move into digital imaging for radiography and R/F applications. The package includes a Tosrad multipurpose radiography system, an Efficiency 450D angiography and R/F table, and an Agfa CR starter kit, according to Don Volz, director of the x-ray business unit.
• Toshiba executives revealed that the company is developing digital flat-panel detectors. Toshiba’s work-in-progress detector is based on amorphous selenium, and the company hopes to be able to offer a unit that can conduct both static and dynamic studies. Volz believes that a commercial product is probably 18 to 24 months from market.
• In analog x-ray, Infinix is a new line of floor-mounted positioners, which have been incorporated into the company’s Dual C system. Angio-Link 1000 is an off-line review station for cost-effective transfer, review, and postprocessing of angiography images.

Trex Medical

• Trex of Danbury, CT, displayed its Trex 4000M digital radiography system, which is based on a CCD detector supplied by Advanced Instrument Development (SCAN 7/22/98). As a work-in-progress, Trex featured 5000ST, a digital x-ray system with a bucky-style digital detector. Panels in Trex’s booth discussed digital radiography and fluoroscopy using amorphous silicon flat-panel detectors that could be integrated with Trex’s radiography systems.
• On the conventional x-ray side, Trex displayed DigiMax, a tilting C-arm designed as a multipurpose interventional R/F system. Meanwhile, Trex’s Bennett division unveiled a new line of 100-KHz generators, called the Vision HF Series. The generators are used with Bennett’s new Millennium radiography systems.

Varian Associates

• Varian’s VIP-9 flat-panel digital fluoroscopy panels received heightened attention thanks to the 510(k) clearance Picker earned for its Live-X digital fluoroscopy system, which uses the panels. Palo Alto, CA-based Varian is supplying the detectors to other OEMs besides Picker, including Instrumentarium, XiTec, and several firms that Varian is not at liberty to mention. Each firm must receive clearance for its own configuration of the technology.

Wuestec Medical

• This Mobile, AL, company has entered the digital x-ray race with DX-1480, a table-based system using a CCD detector developed in collaboration with Korean electronics giant Samsung. DX-1480 uses two CCD chips, with 16-bit resolution in a 3K x 3K matrix. The system received FDA clearance in October, and Wuestec plans to undercut its digital competitors by selling a complete unit for a list price of about $200,000. Production shipments of DX-1480 will begin in May.