510(k) · Cleared
ClearedImsure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prodigm, Inc. · IYE Accelerator, Linear, Medical
Cleared on Aug 29, 2003 as substantially equivalent to K010464 (Lifeline Software, Inc., 2001) after a 64-day review. Its family tree reaches back 1 generation to 2001. 6 later devices descend from it.
- Decided
- Aug 29, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010464 (2001). 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK010464 Radcalc, Model V.4.0Lifeline Software, Inc. · 2001
- This deviceK031975 ImsureProdigm, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK191944 MU2netDosisoft · 2019
- Descendant · 2 generations on · 1 of its ownK231573 ThinkQA (Edition 2)Dosisoft SA · 2024
- Descendant · cites it directly · 1 of its ownK082606 Commissioning Data Management System (CDMS)D3 Radiation Planning · 2008
- Descendant · 3 generations on · 0 of its ownK252937 ThinkQA 3Dosisoft SA · 2026
- Descendant · cites it directly · 0 of its ownK090182 Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191944MU2netDosisoft · 2019 · cites it directly2descendants
- K231573ThinkQA (Edition 2)Dosisoft SA · 2024 · 2 generations on1descendant
- K082606Commissioning Data Management System (CDMS)D3 Radiation Planning · 2008 · cites it directly1descendant
- K252937ThinkQA 3Dosisoft SA · 2026 · 3 generations on0descendants
- K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010464 | Radcalc, Model V.4.0 | Lifeline Software, Inc. | 2001 | — |
| 0 (this device) | K031975 | Imsure | Prodigm, Inc. | 2003 | — |
| +1 | K191944 | MU2net | Dosisoft | 2019 | — |
| +2 | K231573 | ThinkQA (Edition 2) | Dosisoft SA | 2024 | — |
| +1 | K082606 | Commissioning Data Management System (CDMS) | D3 Radiation Planning | 2008 | — |
| +3 | K252937 | ThinkQA 3 | Dosisoft SA | 2026 | — |
| +1 | K090182 | Module Integrated Radiotherapy System (Mirs) | Nuclemed S.A. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K010464 | Radcalc, Model V.4.0 | 2001 |
What descends from it? (6)
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?
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?
IMSure is indicated for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics data for plans of known geometry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031975 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031975: Imsure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031975
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