Company ยท US
Sensus Healthcare, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2019. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2019 | K190255 | Sensus Healthcare TVM Balloon Applicator Sensus Healthcare, Inc. | JAD |
| Feb 21, 2019 | K182665 | Sensus TPS Workstation Sensus Healthcare, Inc. | MUJ |
| Feb 21, 2019 | K182641 | Sensus IORT System Sensus Healthcare, Inc. | JAD |
| Mar 23, 2018 | K173425 | SRT-100+ Sensus Healthcare, Inc. | JAD |
| Oct 16, 2015 | K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities Sensus Healthcare | JAD |
| Aug 28, 2013 | K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM Sensus Healthcare | JAD |
| May 14, 2013 | K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 Sensus Healthcare | JAD |
Latest recalls
| 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 | K150037 |