# K091602: Mucheck V8

- Pathway: 510(k) (Traditional)
- Applicant: Oncology Data Systems, Inc.
- Decided: Jun 18, 2009 after 15 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: 5 generations back to K914808 (1992). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012227: Mucheck - Monitor Unit Validation Program, Model V4.1, Oncology Data Systems, Inc. (2001) Summary page 1.
- K061152: Mucheck V7.0, Oncology Data Systems, Inc. (2006) Summary page 1.
- K061540: Leksell Gammaplan, Elekta Instrument AB (2006) Summary page 1.

## Most influential descendants
- K102583: Mucheck, Version 9.0 (2010), 0 descendants of its own

## Indications for use
MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system. The intended use of the MuCheck software has been extended to include an optional. module, Gamma-Knife QA Check to independently verify the dose for single or multiple points that have been previously calculated by the Gamma Knife treatment planning system or other points as determined by the physicist.

Source page: https://510kreport.com/device/K091602
Methodology: https://510kreport.com/methodology