# K100801: Puma Model Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Prowess, Inc.
- Decided: Jun 18, 2010 after 88 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: 2 generations back to K913612 (1991). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972275: Lantis Treatstation, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K091132: 4D Integrated Treatment Console, Varian Medical Systems (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K122616: Panther Ois/R & V Model Version 2.0 (2012), 1 descendant of its own
- K211760: Panther OIS (2021), 0 descendants of its own

## Indications for use
The intended use of Puma is to allow the radiation therapist to deliver treatment to the patient via linear accelerator (linac). This entails selection of the patient, selection of the day's correct treatment for the patient, Set tip, and delivery of the treatment fields and recording of the treatment. Puma supports auto-sequencing, a process of automatically downloading a group of fields or segments from the record and verify systemn to the control of the linear accelerator sequentially, without user intervention. In addition, Puma also supports IMRT (Intensity Modulated Radiation Therapy), a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

Source page: https://510kreport.com/device/K100801
Methodology: https://510kreport.com/methodology