Sensus Healthcare, Inc.
FDA Regulatory Profile
Sensus Healthcare, Inc. appears in FDA public data with 1 recall, 7 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1235-2023, Class II) was initiated on February 10, 2023. Its most recent 510(k) clearance was granted on February 21, 2019.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1235-2023 | Class II | Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superfi | February 10, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190255 | Sensus Healthcare TVM Balloon Applicator | February 21, 2019 |
| K182665 | Sensus TPS Workstation | February 21, 2019 |
| K182641 | Sensus IORT System | February 21, 2019 |
| K173425 | SRT-100+ | March 23, 2018 |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities | October 16, 2015 |
| K131582 | SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM | August 28, 2013 |
| K123985 | SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 | May 14, 2013 |