# K231825: Panther TPS

- Pathway: 510(k) (Traditional)
- Applicant: Prowess, Inc.
- Decided: Dec 15, 2023 after 177 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: 10 generations back to K914698 (1992). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193459: Panther Stereotactic, Prowess, Inc. (2020) Summary page 4.

## Indications for use
IMRT – the IMRT module provides treatment planning for intensity-modulated radiation therapy (IMRT) using external photon beams. RealART – the RealART module is intended to provide online correction of the position and shape of the beam portals based on the images acquired on the treatment day when the patient is in the treatment position. ProArc – the ProArc module is intended to support treatment planning by creating treatment plans for intensity-modulated arc radiation therapy. Stereotactic – the Stereotactic module is intended to support highly advanced precision-targeted radiation planning.

Source page: https://510kreport.com/device/K231825
Methodology: https://510kreport.com/methodology