# K122616: Panther Ois/R & V Model Version 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Prowess, Inc.
- Decided: Dec 21, 2012 after 116 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: 4 generations back to K001643 (2000). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120067: Mosaiq Oncology Information System, Impac Medical Systems, Inc. (2012) Summary page 1.
- K093527: Aria Radiation Oncology with Mirs, Varian Medical Systems, Inc. (2009) Summary page 1.
- K091132: 4D Integrated Treatment Console, Varian Medical Systems (2009) Summary page 1.
- K100801: Puma Model Version 1.0, Prowess, Inc. (2010) Summary page 1.

## Most influential descendants
- K211760: Panther OIS (2021), 0 descendants of its own

## Indications for use
Panther oSR&V is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allowis the userto: * 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. * Monitor and track treatment progress. * When Panther 0151 R&V is acting as an R&V system, verify the delivery device's settings against the planned parameters, record the treatment parameters settings and prevent treatment if the parameters are out of tolerance.

Source page: https://510kreport.com/device/K122616
Methodology: https://510kreport.com/methodology