Intended Use

To visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. Generates digital X-ray images from the whole body including skull, chest, abdomen, and extremities to support diagnostic and/or therapeutic decisions.

Technology

Modular stationary X-ray system with components including ceiling suspension with X-ray tube, Bucky wall stand/table, updated X-ray generator, portable wireless and fixed integrated detectors, and a new X.wi-D 24 portable wireless detector. AI-based auto-cropping and virtual automatic exposure control selection are also included.

Performance

Non-clinical testing per voluntary standards for safety, performance, and usability was conducted. A clinical customer use test confirmed system stability, usability, and image quality. The new wireless detector was evaluated by a board-certified radiologist and images were deemed adequate for radiography.

Predicate Devices

No predicate devices specified

Ready to Sharpen Your Edge?

Subscribe to join 7,100+ peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.