510(k) · Cleared
ClearedVision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Mar 11, 2005 as substantially equivalent to K952313 (Varian Assoc., Inc., 1995) and 1 other predicate after a 135-day review. Its family tree reaches back 1 generation to 1995. 121 later devices descend from it.
- Decided
- Mar 11, 2005
- Review
- 135 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952313 (1995). 2 ancestors in all. 121 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK952313 Varis Images, Including Ximatron Digital Imaging OptionVarian Assoc., Inc. · 1995
- This deviceK042956 VisionVarian Medical Systems, Inc. · 2005
- Descendant · cites it directly · 99 of its ownK112930 Mobile MimMim Software, Inc. · 2011
- Descendant · 2 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- Descendant · 3 generations on · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- Descendant · 4 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · 4 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · See all- K112930Mobile MimMim Software, Inc. · 2011 · cites it directly99descendants
- K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 2 generations on68descendants
- K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · 3 generations on67descendants
- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 4 generations on54descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 4 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952313 | Varis Images, Including Ximatron Digital Imaging Option | Varian Assoc., Inc. | 1995 | — |
| 0 (this device) | K042956 | Vision | Varian Medical Systems, Inc. | 2005 | — |
| +1 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| +2 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| +3 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| +4 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +4 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 13 | 0 |
| 2022 | 11 | 0 |
| 2023 | 14 | 0 |
| 2024 | 10 | 0 |
| 2025 | 15 | 0 |
| 2026 | 17 | 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? (2)
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 |
|---|---|---|---|
| * | K952313 | Varis Images, Including Ximatron Digital Imaging OptionSummary page 1…II Product Code: 90 LLZ 3. Predicate Devices: a. Varis Images including Ximatron Digital Imaging option, K952313 b. Varis 1.4g, K001643 4. Description of the Device: The name Varis Images has changed to Vision. The… | 1995 |
| * | K001643 | Varis 1.4GSummary page 1…Product Code: 90 LLZ 3. Predicate Devices: a. Varis Images including Ximatron Digital Imaging option, K952313 b. Varis 1.4g, K001643 4. Description of the Device: The name Varis Images has changed to Vision. The Vision product is a treatment plan… | 2000 |
What descends from it? (121)
See all 1213 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?
Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042956 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042956: Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042956
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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