# K032456: Prowess

- Pathway: 510(k) (Traditional)
- Applicant: Prowess, Inc.
- Decided: Oct 16, 2003 after 66 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021268: Eclipse, Helios Option, Varian Medical Systems, Inc. (2002)
- K940663: Peacock Plan, Nomos Corp. (1996) Summary page 1.
- K002237: P3IMRT TM, Adac Laboratories (2001) Summary page 2.
- K980379: Prowess Pro-Sim, Ssgi Prowess Systems (1998) Summary page 1.

## Indications for use
Prowess 3D Radiation Therapy Treatment Planning System, including the IMRT option Panther, is used to plan photon and electron radiation therapy treatments using linear accelerators and Cobalt-60 beams. The optional software module with the trade name Panther provides treatment planning for intensity-modulated radiation therapy (IMRT) treatments using external photon beams.

Source page: https://510kreport.com/device/K032456
Methodology: https://510kreport.com/methodology