510(k) · Cleared
ClearedMucheck V8
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 Jun 18, 2009 as substantially equivalent to K012227 (Oncology Data Systems, Inc., 2001) and 2 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Jun 18, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K914808 (1992). 12 ancestors in all, the oldest K911612 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK914808 Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 1992
- 4 generations backK973441 Leksell GammaplanPatterson Consulting Group, Inc. · 1998 · Recalled
- 3 generations backK042269 Leksell Gammaplan 4C with MultiviewElekta Instrument AB · 2004
- 2 generations backK051022 GammaplanElekta Instrument AB · 2005
- 1 generation backK061540 Leksell GammaplanElekta Instrument AB · 2006
- This deviceK091602 Mucheck V8Oncology Data Systems, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK102583 Mucheck, Version 9.0Oncology Data Systems, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K102583Mucheck, Version 9.0Oncology Data Systems, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914808 | Leksell Gammaplan (LGP) | Elekta Instruments, Inc. | 1992 | — |
| −4 | K973441 | Leksell Gammaplan | Patterson Consulting Group, Inc. | 1998 | 4 |
| −3 | K042269 | Leksell Gammaplan 4C with Multiview | Elekta Instrument AB | 2004 | — |
| −2 | K051022 | Gammaplan | Elekta Instrument AB | 2005 | — |
| −1 | K061540 | Leksell Gammaplan | Elekta Instrument AB | 2006 | — |
| 0 (this device) | K091602 | Mucheck V8 | Oncology Data Systems, Inc. | 2009 | — |
| +1 | K102583 | Mucheck, Version 9.0 | Oncology Data Systems, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1Summary page 1…ed under section 514 Substantial Equivalence: Device Name .510(K) Number MuCheck Monitor Unit Validation (V4 for IMRT) K012227 MuCheck Monitor Unit Validation (V7 for Brachy) K061 152 Leksell GamnmaPlan K061 540 De… | 2001 |
| * | K061152 | Mucheck V7.0Summary page 1….510(K) Number MuCheck Monitor Unit Validation (V4 for IMRT) K012227 MuCheck Monitor Unit Validation (V7 for Brachy) K061 152 Leksell GamnmaPlan K061 540 Description: The Gamma-Knife QA Check Program is a software progr… | 2006 |
| * | K061540 | Leksell GammaplanSummary page 1…Monitor Unit Validation (V4 for IMRT) K012227 MuCheck Monitor Unit Validation (V7 for Brachy) K061 152 Leksell GamnmaPlan K061 540 Description: The Gamma-Knife QA Check Program is a software program that is designed to operate on an IBM compatible personal co… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102583 | Mucheck, Version 9.0 | 2010 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K102583 (Oncology Data Systems, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K012227.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091602: Mucheck V8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091602
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026