# K182665: Sensus TPS Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Sensus Healthcare, Inc.
- Decided: Feb 21, 2019 after 149 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K864210 (1986). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171885: Radiance V4, Gmv Soluciones Globales Internet S.A.U. (2017) Summary page 11.

## Indications for use
Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System, a device suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.

Source page: https://510kreport.com/device/K182665
Methodology: https://510kreport.com/methodology