Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sensus Healthcare, Inc. with 7 510(k) clearances and 1 device recall. The most recent is a device recall dated Feb 10, 2023: Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 10, 2023 | Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System withClass II · When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dos | Device recalls |
| Feb 21, 2019 | Sensus TPS WorkstationK182665 · MUJ | 510(k) clearances |
| Feb 21, 2019 | Sensus Healthcare TVM Balloon ApplicatorK190255 · JAD | 510(k) clearances |
| Feb 21, 2019 | Sensus IORT SystemK182641 · JAD | 510(k) clearances |
| Mar 23, 2018 | SRT-100+K173425 · JAD | 510(k) clearances |
| Oct 16, 2015 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesK150037 · JAD | 510(k) clearances |
| Aug 28, 2013 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEMK131582 · JAD | 510(k) clearances |
| May 14, 2013 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100K123985 · JAD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
