510(k) · Cleared
ClearedEpigray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dosisoft SA · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Feb 8, 2012 as substantially equivalent to K101503 (Math Resolutions, LLC, 2010) after a 142-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Feb 8, 2012
- Review
- 142 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010225 (2001). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K153011iViewDose R1.0Elekta Limited · 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) | K112723 | Epigray | Dosisoft SA | 2012 | — |
| +1 | K153011 | iViewDose R1.0 | Elekta Limited | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 1…hone: 33 1 41 2426 26 Fax: 33 141 2426 28 Predicate: Dosimetry Check with Exit Dose from Math Resolutions, LLC (K 101503) Device Descrirtion: EPlgray is comprehensive software that allows the user to perform an in-vivo dosimetry by… | 2010 |
| † | K103146 | Isogray Treatment Planning System | 2011 |
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 |
|---|---|---|---|
| K153011 | iViewDose R1.0 | 2015 | 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 11 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K153011 (Elekta Limited, 2015) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K101503.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
EPigray is a software to be used by radiation oncologist and medical physicist to detect errors in the delivery of high energy X-rays during the course of patient treatment. This product verifies if the reconstructed dose, computed by the system, is in agreement with the planned dose given by the treatment planning system. This product uses the measurements performed by an Electronic Portal Imaging Device (EPID). This product uses the prescription computed by the treatment planning system. This product in not used to give a prescription of the radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112723 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112723: Epigray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112723
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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