Sensus TPS Workstation
FDA 510(k) K182665 · Sensus Healthcare, Inc.
510(k) numberK182665
Submission
- Device name
- Sensus TPS Workstation
- Applicant
- Sensus Healthcare, Inc.
Boca Raton, FL, US - Received
- September 25, 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 MUJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260750 | Virtual Cone (1.0)MUJ · Traditional | Varian Medical Systems, Inc. | 07/08/2026SE |
| K253050 | RadOncAIMUJ · Traditional | Informai | 06/18/2026SE |
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0)MUJ · Traditional | Philips Medical Systems Nederland B.V. | 05/27/2026SE |
| K252784 | eXaSkin PlusMUJ · Traditional | Anatomical Geometry S.L. | 05/22/2026SE |
| K253078 | ART.1-USMUJ · Traditional | Seetreat Pty, Ltd. | 05/14/2026SE |
| K252304 | syngo.via RT Image Suite VC10MUJ · Traditional | Varian Medical Systems, Inc. | 03/18/2026SE |
| K260308 | TrueFit BolusMUJ · Special | Adaptiiv Medical Technologies, Inc. | 02/19/2026SE |
| K252002 | Monaco RTP System (6.3)MUJ · Traditional | Elekta Solutions AB | 02/19/2026SE |
| K253091 | ART-Plan+ (v3.1.0)MUJ · Traditional | Therapanacea Sas | 12/23/2025SE |
| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
More from RaySearch Laboratories AB (PUBL)
| 510(k) | Device | Decision |
|---|---|---|
| K190255 | Sensus Healthcare TVM Balloon ApplicatorJAD · Traditional | 02/21/2019SE |
| K182641 | Sensus IORT SystemJAD · 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 TPS Workstation cleared by the FDA?
Sensus TPS Workstation (K182665) received a 510(k) decision of Substantially Equivalent on February 21, 2019, 149 days after the submission was received.
What is the product code of K182665?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.