510(k) K150037 ยท JAD System, Therapeutic, X-Ray
Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
| Applicant | Sensus Healthcare, Boca Raton FL, US |
| Decision | Substantially Equivalent, Oct 16, 2015 |
| Received | Jan 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2023 | Sensus Healthcare, Inc. Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities Terminated |
JAD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.