510(k) · Cleared
ClearedDusimetry Check
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Math Resolutions, LLC · IYE Accelerator, Linear, Medical
Cleared on Aug 4, 2010 as substantially equivalent to K010225 (Math Resolutions, LLC, 2001) after a 64-day review. Its family tree reaches back 1 generation to 2001. 8 later devices descend from it.
- Decided
- Aug 4, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010225 (2001). 8 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK010225 Dosimetry CheckMath Resolutions, LLC · 2001
- This deviceK101503 Dusimetry CheckMath Resolutions, LLC · 2010
- Descendant · cites it directly · 4 of its ownK132605 Dosimetry Check Version 4 Release 1Math Resolutions, LLC · 2013
- Descendant · cites it directly · 1 of its ownK112723 EpigrayDosisoft SA · 2012
- Descendant · cites it directly · 0 of its ownK170345 SoftdisoBest Nomos · 2017
- Descendant · 2 generations on · 0 of its ownK162577 Dosimetry Check Version 5 Release 1Math Resolutions, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK152994 AdaptivoAurora Technology Development, LLC · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K132605Dosimetry Check Version 4 Release 1Math Resolutions, LLC · 2013 · cites it directly4descendants
- K112723EpigrayDosisoft SA · 2012 · cites it directly1descendant
- K170345SoftdisoBest Nomos · 2017 · cites it directly0descendants
- K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC · 2016 · 2 generations on0descendants
- K152994AdaptivoAurora Technology Development, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010225 | Dosimetry Check | Math Resolutions, LLC | 2001 | — |
| 0 (this device) | K101503 | Dusimetry Check | Math Resolutions, LLC | 2010 | — |
| +1 | K132605 | Dosimetry Check Version 4 Release 1 | Math Resolutions, LLC | 2013 | — |
| +1 | K112723 | Epigray | Dosisoft SA | 2012 | — |
| +1 | K170345 | Softdiso | Best Nomos | 2017 | — |
| +2 | K162577 | Dosimetry Check Version 5 Release 1 | Math Resolutions, LLC | 2016 | — |
| +2 | K152994 | Adaptivo | Aurora Technology Development, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K010225 | Dosimetry Check | 2001 |
What descends from it? (8)
5 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?
- Its one ancestor has no recall.
- Of its descendants, K132605 (Math Resolutions, LLC, 2013) has gone furthest, with 4 descendants of its own.
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?
The product is to be used by radiation oncologist, dosimetrist, and radiation therapy physicist to check the correctness of the x-ray treatment fields from high energy treatment machines that are planned to be or have been applied to a patient. This product is to be used in addition to the treatment planning system to provide a means for additional and redundant verification that the plan is in fact successfully accomplished. This product is not a…
Read the full statement (158 words)
The product is to be used by radiation oncologist, dosimetrist, and radiation therapy physicist to check the correctness of the x-ray treatment fields from high energy treatment machines that are planned to be or have been applied to a patient. This product is to be used in addition to the treatment planning system to provide a means for additional and redundant verification that the plan is in fact successfully accomplished. This product is not a treatment planning system and is not to be used as one. This product only checks the applied dose based on the measurement of each x-ray field and a theoretical calculation. This product does not provide any quality assurance that the fields are, in fact correctly applied to and correctly aligned with the patient anatomy as planned. In addition, the product may be used to display the above dose on other fused image sets which could provide additional clinical information to the radiation oncologist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101503: Dusimetry Check.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101503
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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