The following data is part of a premarket notification filed by Sensus Healthcare, Inc. with the FDA for Sensus Tps Workstation.
| Device ID | K182665 |
| 510k Number | K182665 |
| Device Name: | Sensus TPS Workstation |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Sensus Healthcare, Inc. 851 Broken Sound Parkway NW Suite 215 Boca Raton, FL 33487 |
| Contact | Nicolas Soro |
| Correspondent | Nicolas Soro Sensus Healthcare, Inc. 851 Broken Sound Parkway NW Suite 215 Boca Raton, FL 33487 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-25 |
| Decision Date | 2019-02-21 |
| Summary: | summary |