Sensus IORT System
FDA 510(k) K182641 · Sensus Healthcare, Inc.
510(k) numberK182641
Submission
- Device name
- Sensus IORT System
- Applicant
- Sensus Healthcare, Inc.
Boca Raton, FL, US - Received
- September 24, 2018
- Decision date
- February 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250692 | GentleBeam (GB1000)JAD · Traditional | Voxel Ray Solutions, LLC | 12/03/2025SE |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…JAD · Traditional | Carl Zeiss Meditec, AG | 01/10/2025SE |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)JAD · Traditional | Xstrahl, Ltd. | 07/13/2023SE |
| K213942 | EsteyaJAD · Traditional | Nucletron B.V. | 01/11/2022SE |
| K190255 | Sensus Healthcare TVM Balloon ApplicatorJAD · Traditional | Sensus Healthcare, Inc. | 02/21/2019SE |
| K173425 | SRT-100+JAD · Traditional | Sensus Healthcare, Inc. | 03/23/2018SE |
| K172080 | Photoelectric Therapy SystemJAD · Traditional | Xstrahl, Ltd. | 09/29/2017SE |
| K162568 | Intrabeam 600JAD · Traditional | Carl Zeiss Meditec, AG | 12/15/2016SE |
| K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200JAD · Traditional | Icad, Inc. | 02/25/2016SE |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging…JAD · Traditional | Sensus Healthcare | 10/16/2015SE |
More from Sensus Healthcare
| 510(k) | Device | Decision |
|---|---|---|
| K190255 | Sensus Healthcare TVM Balloon ApplicatorJAD · Traditional | 02/21/2019SE |
| K182665 | Sensus TPS WorkstationMUJ · Traditional | 02/21/2019SE |
| K173425 | SRT-100+JAD · Traditional | 03/23/2018SE |
| K150037 | Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging…JAD · Traditional | 10/16/2015SE |
| K131582 | Sensus Helthcare Image-Duided Superficial Radiotherapy SystemJAD · Traditional | 08/28/2013SE |
| K123985 | Sensus Healthcare Superficial Radiotherapy System SRT-100JAD · Traditional | 05/14/2013SE |
Questions and answers
When was Sensus IORT System cleared by the FDA?
Sensus IORT System (K182641) received a 510(k) decision of Substantially Equivalent on February 21, 2019, 150 days after the submission was received.
What is the product code of K182641?
The FDA product code is JAD – System, Therapeutic, X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.