Data / Medical devices / United States / Sensus Healthcare
Sensus Healthcare: FDA-registered device maker in Boca Raton, FL, United States, 3 510(k) clearances
Sensus Healthcare is registered with the FDA (registration 3008513398) in Boca Raton, FL, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated March 23, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008513398
- Address
- 851 Broken Sound Pkwy. NW#215, Boca Raton, FL, United States, 33487
- Owner or operator
- Sensus Healthcare (10033258)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 16, 2016
- Registered through
- 2026
- Brand names listed
- SRT-100, SRT-100 Vision, SRT-100+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Therapeutic, X-Ray | JAD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 23, 2018 | K173425 | SRT-100+ | JAD | Substantially Equivalent | Sensus Healthcare, Inc. | accessdata.fda.gov |
| October 16, 2015 | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | JAD | Substantially Equivalent | Sensus Healthcare | accessdata.fda.gov |
| May 14, 2013 | K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | JAD | Substantially Equivalent | Sensus Healthcare | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 10, 2023 | 91795 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
Updated March 8, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.