FDA Grants 510(k) Clearance to Chiropractic Straight Arm Radiography System

The new Chiropractic Straight Arm (CSA) system with Dynamic Digital Radiography (DDR) has garnered 510(k) clearance from the Food and Drug Administration (FDA), according to 20/20 Imaging, a division of Konica Minolta Healthcare Americas, Inc.

The company said the DDR technology allows low-cost, high-speed capture of static and dynamic images. A cine loop with the DDR technology allows one view acquisition on conventional digital radiography to provide up to a 20-second snapshot of anatomical motion, according to 20/20 Imaging.

Other features of the compact CSA include detailed bone and soft tissue visualization with a 17” x 17” field of view detector as well as predetermined anatomy-specific patient positioning to help simplify workflow. The company emphasized that flexibility and range of motion of the CSA system accommodate a variety of patient positioning needs from standing to lying on a table and those using wheelchairs.

20/20 Imaging also noted the combination of CSA and DDR enables one to obtain dynamic views of the cervical spine during flexion and extension, a key attribute that can be helpful with the documentation of whiplash injuries.

“CSA with DDR is the next-generation imaging solution allowing chiropractors to examine and measure a patient’s biomechanics and musculoskeletal injury, including whiplash, and more confidently evaluate treatment follow-up,” noted Bob Salzman, the president of 20/20 Imaging. “Designed to boost clinical capabilities to the next level by capturing patient movement, CSA with DDR gives chiropractors the immediate results they need to make informed decisions faster.”