510(k) · Cleared
ClearedMucheck - Monitor Unit Validation Program, Model V4.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oncology Data Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Oct 1, 2001 as substantially equivalent to K980904 (Medical Dosimetry Services, Inc., 1998) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1992. 40 later devices descend from it.
- Decided
- Oct 1, 2001
- Review
- 77 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914698 (1992). 3 ancestors in all. 40 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 1 generation backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- This deviceK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- Descendant · cites it directly · 31 of its ownK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- Descendant · 2 generations on · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- Descendant · cites it directly · 21 of its ownK061152 Mucheck V7.0Oncology Data Systems, Inc. · 2006
- Descendant · 2 generations on · 17 of its ownK090531 Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009
- Descendant · 3 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K072374CompassScanditronix Wellhofer GmbH · 2007 · cites it directly31descendants
- K140660MOBIUS3DMobius Medical Systems, LP · 2014 · 2 generations on23descendants
- K061152Mucheck V7.0Oncology Data Systems, Inc. · 2006 · cites it directly21descendants
- K090531Radcalc Software, Version 6.0Lifeline Software, Inc. · 2009 · 2 generations on17descendants
- K153014Mobius3DMobius Medical Systems, LP · 2016 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −1 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| 0 (this device) | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| +1 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| +2 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| +1 | K061152 | Mucheck V7.0 | Oncology Data Systems, Inc. | 2006 | — |
| +2 | K090531 | Radcalc Software, Version 6.0 | Lifeline Software, Inc. | 2009 | — |
| +3 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980904 | Mucheck Monitor Unit Validation ProgramSummary page 1…apy System(Accessory) 21 CFR 892.5050 (class II) Performance Standards: none established under section 514 Substantial Equivalence: mucheck — Monitor Unit Validation(K980904) RadCalc (K010464) Description: The muCheck Monitor Unit Validation Program is a software program that is designed to operate o… | 1998 |
| * | K010464 | Radcalc, Model V.4.0Summary page 1…ry) 21 CFR 892.5050 (class II) Performance Standards: none established under section 514 Substantial Equivalence: mucheck — Monitor Unit Validation(K980904) RadCalc (K010464) Description: The muCheck Monitor Unit Validation Program is a software program that is designed to operate on an IBM compatibl… | 2001 |
What descends from it? (40)
See all 403 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K072374 (Scanditronix Wellhofer GmbH, 2007) has gone furthest, with 31 descendants of its own.
- 2 other devices also cite its predicate K980904.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012227: Mucheck - Monitor Unit Validation Program, Model V4.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012227
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026