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Sign in to claim this brandSensus Healthcare
United States·US-MF-000037246
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 851, Broken Sound Pkwy NW, Boca Raton, United States
- Website
- sensushealthcare.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Mike Racasan
- EUDAMED SRN
- US-MF-000037246
- FDA FEI Number
- 3008513398
- DUNS Number
- —
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sensus | SRT-100+ | FDA UDI | Class II | Active |
| Sensus | SRT-100 Vision | EUDAMEDFDA UDI | Class II | Active |
| Srt-100+ | K173425 | FDA 510(k) | Class II | Active |
| Sensus Helthcare Image-Duided Superficial Radiotherapy System | K131582 | FDA 510(k) | Class II | Active |
| Sensus TPS Workstation | K182665 | FDA 510(k) | Class II | Active |
| Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | K150037 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Sensus Healthcare TVM Balloon Applicator | K190255 | FDA 510(k) | Class II | Active |
| Sensus IORT System | K182641 | FDA 510(k) | Class II | Active |
| Sensus Healthcare Superficial Radiotherapy System Srt-100 | K123985 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 10, 2023 | Z-1235-2023 | — | terminated | When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient. |