FDA 483 - Sensus Healthcare, Inc. - August 05, 2022

Sensus Healthcare, Inc. in Boca Raton, FL, a medical device specification developer, was inspected regarding its design activities. The inspection revealed inadequate documentation of design verification results for its SRT-100+ System, a low energy x-ray system. This included issues with verifying software requirements for power failure indications and radiation emission termination, as well as documentation for operating temperature range testing.