510(k) Report

FDA applicant

Sensus Healthcare, Inc.

Boca Raton, FL7 decisions2013–20191 recall

FDA records 7 decisions for Sensus Healthcare, Inc. (Boca Raton, FL) from 2013 to 2019: 7 510(k) clearances. Most are in product codes JAD (System, Therapeutic, X-Ray) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 9 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Sensus Healthcare”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Sensus Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2019

2013: 22015: 12018: 12019: 3
2013high 3 (2019) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2013high 1 (2023) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Sensus Healthcare, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sensus Healthcare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JADSystem, Therapeutic, X-Ray6decisions
  • MUJSystem, Planning, Radiation Therapy Treatment1decision

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesSensus Healthcare · 20153cite it
  • K123985Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare · 20132cite it
  • K131582Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSensus Healthcare · 20131cites it

What has FDA decided for it lately?

  • K182641Sensus IORT SystemSensus Healthcare, Inc. · 2019
  • K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc. · 2019
  • K182665Sensus TPS WorkstationSensus Healthcare, Inc. · 2019
  • K173425SRT-100+Sensus Healthcare, Inc. · 2018
  • K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesSensus Healthcare · 20151 recall
  • K131582Sensus Helthcare Image-Duided Superficial Radiotherapy SystemSensus Healthcare · 2013
  • K123985Sensus Healthcare Superficial Radiotherapy System SRT-100Sensus Healthcare · 2013

All 4 as Sensus Healthcare, Inc. →All 3 as Sensus Healthcare →

What has been recalled?

1 recall linked to its devices; the latest:

  • K150037Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version…Feb 10, 2023Class II