510(k) · Cleared
ClearedDosimetry Check Version 4 Release 1
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 Nov 14, 2013 as substantially equivalent to K101503 (Math Resolutions, LLC, 2010) after an 86-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Nov 14, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010225 (2001). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK010225 Dosimetry CheckMath Resolutions, LLC · 2001
- 1 generation backK101503 Dusimetry CheckMath Resolutions, LLC · 2010
- This deviceK132605 Dosimetry Check Version 4 Release 1Math Resolutions, LLC · 2013
- Descendant · cites it directly · 0 of its ownK162577 Dosimetry Check Version 5 Release 1Math Resolutions, LLC · 2016
- Descendant · cites it directly · 0 of its ownK152994 AdaptivoAurora Technology Development, LLC · 2016
- Descendant · cites it directly · 0 of its ownK153011 iViewDose R1.0Elekta Limited · 2015
- Descendant · cites it directly · 0 of its ownK143269 Delivery AnalysisAccuray Incorporated · 2015
Most influential descendants
Showing 4 of 4 · See all- K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC · 2016 · cites it directly0descendants
- K152994AdaptivoAurora Technology Development, LLC · 2016 · cites it directly0descendants
- K153011iViewDose R1.0Elekta Limited · 2015 · cites it directly0descendants
- K143269Delivery AnalysisAccuray Incorporated · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010225 | Dosimetry Check | Math Resolutions, LLC | 2001 | — |
| −1 | K101503 | Dusimetry Check | Math Resolutions, LLC | 2010 | — |
| 0 (this device) | K132605 | Dosimetry Check Version 4 Release 1 | Math Resolutions, LLC | 2013 | — |
| +1 | K162577 | Dosimetry Check Version 5 Release 1 | Math Resolutions, LLC | 2016 | — |
| +1 | K152994 | Adaptivo | Aurora Technology Development, LLC | 2016 | — |
| +1 | K153011 | iViewDose R1.0 | Elekta Limited | 2015 | — |
| +1 | K143269 | Delivery Analysis | Accuray Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K101503 | Dusimetry CheckSummary page 2…information to the user regarding the correctness of treatment. Identification of the Legally Marketed Dosimetry Check version 3 release 1, K101503 Device (Predicate Device Device System 2 100 for which 5 10O(k) K993530 was cleared by the FDA on Description… | 2010 |
| † | K993530 | System 2100 | 1999 |
What descends from it? (4)
4 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 12 years and passes through 1 company; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162577 (Math Resolutions, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K101503.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to or have been applied to a patient, and computing the dose to the patient from…
Read the full statement (301 words)
Dosimetry Check is a standalone software product intended to be used by an experienced radiological physicist for quality control purposes only. Dosimetry Check is intended to check the correctness of x-ray treatment plans delivered from high energy charged-particle radiation therapy treatment machines by using a measurement of the applied radiation fields that are planned to or have been applied to a patient, and computing the dose to the patient from the measured radiation fields. This product is to be used as a quality control check for the treatment planning system and delivery system.
Dosimetry Check quality control software uses the radiation fields that are measured with media such as x-ray film, electronic portal imaging devices (EPID). diode or ion chamber arrays, or in the case of TomoTherapy. a fan line detector array, and provides a theoretical calculation. Dosimetry Check computes the dose and dose distribution using the patient specific computed tomography (CT) or other image set or alternately a phantom that is likewise scanned, to calculate the reconstructed dose that is then compared to the plan dose. The results reported can include the computed percent difference at specific point as compared to the patient specific radiation treatment plan.
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 applied to the patient and provided in an exported file, 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 supportive quality information to the user regarding the correctness of treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132605: Dosimetry Check Version 4 Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132605
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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