SRT-100+
FDA 510(k) clearance K173425 · decided 2018-03-23
Clearance details
- K-number
- K173425
- Device name
- SRT-100+
- Applicant
- Sensus Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-11-02
- Decision date
- 2018-03-23
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Boca Raton, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GentleBeam (GB1000) (K250692) | Voxel Ray Solutions, LLC | 2025-12-03 |
| INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (K241174) | Carl Zeiss Meditec, AG | 2025-01-10 |
| X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (K230611) | Xstrahl, Ltd. | 2023-07-13 |
| Esteya (K213942) | Nucletron B.V. | 2022-01-11 |
| Sensus Healthcare TVM Balloon Applicator (K190255) | Sensus Healthcare, Inc. | 2019-02-21 |
| Sensus IORT System (K182641) | Sensus Healthcare, Inc. | 2019-02-21 |
| Photoelectric Therapy System (K172080) | Xstrahl, Ltd. | 2017-09-29 |
| INTRABEAM 600 (K162568) | Carl Zeiss Meditec, AG | 2016-12-15 |
| Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570) | Icad, Inc. | 2016-02-25 |
| Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (K150037) | Sensus Healthcare | 2015-10-16 |
| AXXENT CERVICAL APPLICATOR (K141343) | Icad, Inc. | 2014-09-05 |
| ESTEYA (K132092) | Nucletron B.V. | 2013-09-26 |
Recalls involving this device
No recalls on record reference this clearance.