# K012227: Mucheck - Monitor Unit Validation Program, Model V4.1

- Pathway: 510(k) (Traditional)
- Applicant: Oncology Data Systems, Inc.
- Decided: Oct 1, 2001 after 77 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 K914698 (1992). 3 ancestors in all.
40 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980904: Mucheck Monitor Unit Validation Program, Medical Dosimetry Services, Inc. (1998) Summary page 1.
- K010464: Radcalc, Model V.4.0, Lifeline Software, Inc. (2001) Summary page 1.

## Most influential descendants
- K072374: Compass (2007), 31 descendants of its own
- K140660: MOBIUS3D (2014), 23 descendants of its own
- K061152: Mucheck V7.0 (2006), 21 descendants of its own
- K090531: Radcalc Software, Version 6.0 (2009), 17 descendants of its own
- K153014: Mobius3D (2016), 13 descendants of its own

## Indications for use
The muCheck - Monitor Unit Validation Program (the device under review) verifies the monitor unit or dose calculated by the primary treatment planning system. It serves as quality assurance as part of good freatment protocol to have a second means to verify the accuracy of the primary calculation. The Intensity Modulated Radiotherapy and Diode corrections features added to the softiare extends the use of the program to verify dose calculations performed by the primary treatment planning system.

Source page: https://510kreport.com/device/K012227
Methodology: https://510kreport.com/methodology