Search Results

The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.

The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.

This document is a 510(k) clearance letter from the FDA for a dental X-ray generator, the "Dental X-Ray Z70." It discusses regulatory aspects but does not contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from the provided text.

The letter explicitly states that the FDA's "substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It is primarily a regulatory clearance and not a detailed study report.

Ask a specific question about this device