# K984196: Modification to Prowess Pro-Sim

- Pathway: 510(k) (Special)
- Applicant: Ssgi Prowess Systems
- Decided: Dec 11, 1998 after 18 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: 3 generations back to K862643 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980379: Prowess Pro-Sim, Ssgi Prowess Systems (1998) Summary page 1.

## Indications for use
Prowess Pro-Sim is a modularly designed radiation therapy treatment planning computer program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can displayed in 3D prior to treatment.

Source page: https://510kreport.com/device/K984196
Methodology: https://510kreport.com/methodology