510(k) · Cleared
ClearedProton Vision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Assoc., Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on May 24, 2000 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 108 later devices descend from it.
- Decided
- May 24, 2000
- Review
- 63 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 0
108 later devices descend from it, 3 citing it directly.
- This deviceK000922 Proton VisionVarian Assoc., Inc. · 2000
- Descendant · cites it directly · 106 of its ownK002312 Proton Vision 7.0Varian Medical Systems, Inc. · 2000
- Descendant · 2 generations on · 101 of its ownK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- Descendant · 3 generations on · 94 of its ownK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 92 of its ownK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 5 generations on · 87 of its ownK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
Showing 5 of 108 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 108 · See all- K002312Proton Vision 7.0Varian Medical Systems, Inc. · 2000 · cites it directly106descendants
- K050296Eclipse Treatment Planning SystemVarian Medical Systems · 2005 · 2 generations on101descendants
- K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 3 generations on94descendants
- K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 4 generations on92descendants
- K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · 5 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000922 | Proton Vision | Varian Assoc., Inc. | 2000 | — |
| +1 | K002312 | Proton Vision 7.0 | Varian Medical Systems, Inc. | 2000 | — |
| +2 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| +3 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| +4 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| +5 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 10 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (108)
See all 1083 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?
- Of its descendants, K002312 (Varian Medical Systems, Inc., 2000) has gone furthest, with 106 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K000922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000922: Proton Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000922
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026