510(k) · Cleared
Recalled · 2003Brachyvision 6.0
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 Mar 9, 2000 after a 205-day review. The FDA summary names its predicate without a number. 189 later devices descend from it. It has been recalled once.
- Decided
- Mar 9, 2000
- Review
- 205 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 0
189 later devices descend from it, 7 citing it directly.
- This deviceK992762 Brachyvision 6.0Varian Assoc., Inc. · 2000
- Descendant · cites it directly · 101 of its ownK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- Descendant · 2 generations on · 94 of its ownK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 92 of its ownK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 87 of its ownK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · cites it directly · 83 of its ownK030534 Variseed 7.1Varian Medical Systems · 2003 · Recalled
Showing 5 of 189 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 189 · See all- K050296Eclipse Treatment Planning SystemVarian Medical Systems · 2005 · cites it directly101descendants
- K071873Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 2 generations on94descendants
- K073020Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · 3 generations on92descendants
- K091492Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · 4 generations on87descendants
- K030534Variseed 7.1Varian Medical Systems · 2003 · cites it directly83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992762 | Brachyvision 6.0 | Varian Assoc., Inc. | 2000 | — |
| +1 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| +2 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| +3 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| +4 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| +1 | K030534 | Variseed 7.1 | Varian Medical Systems | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 11 | 0 |
| 2021 | 18 | 0 |
| 2022 | 15 | 0 |
| 2023 | 20 | 0 |
| 2024 | 13 | 0 |
| 2025 | 16 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | — | Nucletron Plato Brachytherapy Named without a submission number |
What descends from it? (189)
See all 1897 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2003 | Not classified | Z-0176-03 | Other | The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050296 (Varian Medical Systems, 2005) has gone furthest, with 101 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 | — |
What is it indicated for?
BrachyVison 6.0 may be used for any brachytherapy planning activity, but has been specifically optimized for use with remote afterloaders (especially the VariSource unit from Varian), and for use with 3D images such as may be obtained from CT or MRI, or Ultrasound images.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992762: Brachyvision 6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992762
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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