Sensus Healthcare, Inc.August 5, 2022

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

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Record Details

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.

Company: Sensus Healthcare, Inc.
Inspection Date: August 5, 2022
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Stanley B. Eugene (investigator)

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ID · 1158df1c-1413-4c99-a323-403a3463e6fe