# K061152: Mucheck V7.0

- Pathway: 510(k) (Traditional)
- Applicant: Oncology Data Systems, Inc.
- Decided: May 10, 2006 after 14 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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: 3 generations back to K914698 (1992). 6 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983343: Plato Brachytheraphy, Model V. 14.0, Nucletron Corp. (1999) Summary page 1.
- K980904: Mucheck Monitor Unit Validation Program, Medical Dosimetry Services, Inc. (1998) Summary page 1.
- K012227: Mucheck - Monitor Unit Validation Program, Model V4.1, Oncology Data Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K090531: Radcalc Software, Version 6.0 (2009), 17 descendants of its own
- K153014: Mobius3D (2016), 13 descendants of its own
- K191761: Mobius3D (2019), 5 descendants of its own
- K192424: Mobius3D (2019), 4 descendants of its own
- K171350: Collision Check (2017), 4 descendants of its own

## Indications for use
In a radiation therapy department, a course of patient treatment is prescribed by a written directive from a radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the radiation therapy. As part of the planning process monitor unit settings and dose to a volume or specific anatomical points will be generated. The MuCheck - Monitor Unit/Dose validation Software verifies the monitor unit or dose calculated by the primary treatment planning system. MuCheck can also be used to calculate the monitor or dose for simple plans that do not require the use of the primary treatment planning system. The intended use of the MuCheck software has been extended by the addition of an optional module called BrachyCheck. Brachycheck is used to verify brachytherapy procedures(implants using radioactive sources) performed by a brachytherapy treatment planning system. As part of the planning process, dwell positions will be generated and dose contributions from these dwell positions to specified anatomical points will be calculated. The BrachyCheck module (device under review) verifies the dose calculated to the specified points by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.

Source page: https://510kreport.com/device/K061152
Methodology: https://510kreport.com/methodology