510(k) · Cleared
ClearedOmnipro I'mrt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellhofer Dosimetrie · IYE Accelerator, Linear, Medical
Cleared on Aug 29, 2003 as substantially equivalent to K935928 (Radiological Imaging Technology, Inc., 1994) after a 94-day review. Its family tree reaches back 1 generation to 1994. 34 later devices descend from it.
- Decided
- Aug 29, 2003
- Review
- 94 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935928 (1994). 34 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK935928 Rit 113 Film Analysis SystemRadiological Imaging Technology, Inc. · 1994
- This deviceK031634 Omnipro I'mrtWellhofer Dosimetrie · 2003
- Descendant · cites it directly · 31 of its ownK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- Descendant · 2 generations on · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- Descendant · 3 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
- Descendant · 4 generations on · 5 of its ownK191761 Mobius3DVarian Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK141800 PerfractionSun Nuclear Corporation · 2014
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K072374CompassScanditronix Wellhofer GmbH · 2007 · cites it directly31descendants
- K140660MOBIUS3DMobius Medical Systems, LP · 2014 · 2 generations on23descendants
- K153014Mobius3DMobius Medical Systems, LP · 2016 · 3 generations on13descendants
- K191761Mobius3DVarian Medical Systems, Inc. · 2019 · 4 generations on5descendants
- K141800PerfractionSun Nuclear Corporation · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935928 | Rit 113 Film Analysis System | Radiological Imaging Technology, Inc. | 1994 | — |
| 0 (this device) | K031634 | Omnipro I'mrt | Wellhofer Dosimetrie | 2003 | — |
| +1 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| +2 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| +3 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| +4 | K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| +2 | K141800 | Perfraction | Sun Nuclear Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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.
What descends from it? (34)
See all 342 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?
The intended use of the OmniPro I'mRT system is to:
verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment
verify the intensity maps during IMRT delivery prior to treatment
verify the absolute dose in given points for IMRT fields.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031634: Omnipro I'mrt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031634
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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