# K102583: Mucheck, Version 9.0

- Pathway: 510(k) (Traditional)
- Applicant: Oncology Data Systems, Inc.
- Decided: Nov 2, 2010 after 55 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: 6 generations back to K914808 (1992). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091602: Mucheck V8, Oncology Data Systems, Inc. (2009) Summary page 1.

## 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, MuCheck/TomoCheck to independently verify the dose for single point that has been previously calculated by the Tomotherapy Hi Art treatment planning system or other points as determined by the physicist.

Source page: https://510kreport.com/device/K102583
Methodology: https://510kreport.com/methodology