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

Source: https://www.keypedia.com/records/483/sensus-healthcare-inc/1158df1c-1413-4c99-a323-403a3463e6fe

> FDA 483 for Sensus Healthcare, Inc. on August 05, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sensus Healthcare, Inc.
- Inspection Date: 2022-08-05
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/sensus-healthcare-inc/b1845289-dc84-4456-943f-46e31130c00b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6