FDA Publishes Final Guidance on 510(k)s for Solid State X-ray Devices

After issuing draft guidance almost 16 years ago, the FDA issued final guidance that clarifies data required for 510(k) submissions for solid state X-ray imaging devices.

The FDA anticipates a significant number of 510(k) submissions as SSXI technology continues to evolve and replace conventional film/screen X-ray devices.

The guidance clarifies the type of data needed to establish substantial equivalence to a previously cleared conventional radiographic film/screen and image intensifier-based fluoroscopic and image recording systems. — Tamra Sami