510(k) · Cleared
ClearedMucheck, Version 9.0
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 Nov 2, 2010 as substantially equivalent to K091602 (Oncology Data Systems, Inc., 2009) after a 55-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Nov 2, 2010
- Review
- 55 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914808 (1992). 13 ancestors in all, the oldest K911612 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK914808 Leksell Gammaplan (LGP)Elekta Instruments, Inc. · 1992
- 5 generations backK973441 Leksell GammaplanPatterson Consulting Group, Inc. · 1998 · Recalled
- 4 generations backK042269 Leksell Gammaplan 4C with MultiviewElekta Instrument AB · 2004
- 3 generations backK051022 GammaplanElekta Instrument AB · 2005
- 2 generations backK061540 Leksell GammaplanElekta Instrument AB · 2006
- 1 generation backK091602 Mucheck V8Oncology Data Systems, Inc. · 2009
- This deviceK102583 Mucheck, Version 9.0Oncology Data Systems, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914808 | Leksell Gammaplan (LGP) | Elekta Instruments, Inc. | 1992 | — |
| −5 | K973441 | Leksell Gammaplan | Patterson Consulting Group, Inc. | 1998 | 4 |
| −4 | K042269 | Leksell Gammaplan 4C with Multiview | Elekta Instrument AB | 2004 | — |
| −3 | K051022 | Gammaplan | Elekta Instrument AB | 2005 | — |
| −2 | K061540 | Leksell Gammaplan | Elekta Instrument AB | 2006 | — |
| −1 | K091602 | Mucheck V8 | Oncology Data Systems, Inc. | 2009 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K091602 | Mucheck V8Summary page 1…under section 514 Substantial Equivalence: Device Name I ~~~510(K) Number MU~hck oniorJnit Validation (VS for Gamma K09 1602 Description: The MU Check Program-is a software program that is designed-to operate on an-IBM compatible personal computer in a… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102583 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102583: Mucheck, Version 9.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102583
Report an extraction error
Are you the manufacturer?
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