# K211760: Panther OIS

- Pathway: 510(k) (Traditional)
- Applicant: Prowess, Inc.
- Decided: Sep 28, 2021 after 112 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 14 generations back to K954874 (1996). 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)
- K122616: Panther Ois/R & V Model Version 2.0, Prowess, Inc. (2012) Summary page 4.
- K173838: ARIA Radiation Therapy Management, Varian Medical Systems, Inc. (2018) Summary page 4.
- K203172: MOSAIQ Oncology Information System, Elekta Solutions AB (2020) Summary page 4.

## Indications for use
Panther OIS is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allows the user to: • Enter or import, modify, store and archive treatment plans and images from treatment planning systems. • Import, view, manipulate, enhance, annotate, store, and archive radiological images. • Select and provide radiation treatment plans to a radiation treatment delivery system for patient treatment. • Store and view treatment records provided by the radiation treatment delivery system.

Source page: https://510kreport.com/device/K211760
Methodology: https://510kreport.com/methodology