510(k) · Cleared
ClearedVariseed 7.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 12, 2001 as substantially equivalent to K982821 (Multimedia Medical Systems, Inc., 1998) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Jul 12, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924240 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK924240 Prowess 2000Small Systems Group, Inc. · 1993
- 1 generation backK982821 MMS Therpacplus B3DTUI Model Number 6.7Multimedia Medical Systems, Inc. · 1998
- This deviceK012017 Variseed 7.0Varian Medical Systems · 2001
- Descendant · cites it directly · 0 of its ownK143514 Panther StereoSeedProwess, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143514Panther StereoSeedProwess, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924240 | Prowess 2000 | Small Systems Group, Inc. | 1993 | — |
| −1 | K982821 | MMS Therpacplus B3DTUI Model Number 6.7 | Multimedia Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K012017 | Variseed 7.0 | Varian Medical Systems | 2001 | — |
| +1 | K143514 | Panther StereoSeed | Prowess, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
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 18.7 · 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? (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 |
|---|---|---|---|
| * | K982821 | MMS Therpacplus B3DTUI Model Number 6.7Summary page 1…5051 E-Mail [email protected] Device Name: VariSeed 7.0 Classification Name: Soutce, Brachytherapy, Radionuclide Predicate Device: MMS TherapacPLUS B3DTUI, K982821 and Brachyvision, K992762 Page 1 of 2 VARTAN medical systems Oncology Systems 3100 Hansen Way Palo Alto, CA 94304-1038 USA… | 1998 |
| * | K992762 | Brachyvision 6.0Summary page 1….varian.com Device Name: VariSeed 7.0 Classification Name: Soutce, Brachytherapy, Radionuclide Predicate Device: MMS TherapacPLUS B3DTUI, K982821 and Brachyvision, K992762 Page 1 of 2 VARTAN medical systems Oncology Systems 3100 Hansen Way Palo Alto, CA 94304-1038 USA tel +1 650 493 4000 www.… | 2000 |
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 |
|---|---|---|---|
| K143514 | Panther StereoSeed | 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 8 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K143514 (Prowess, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K982821.
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?
VariSeed 7.0 is a software application for planning and evaluating permanent implant
brachytherapy procedures for the treatment of prostate cancer with permanent implants
that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and
post-operative evaluation as well as intra-operative planning and evaluation.
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/K012017 · printed Nov 3, 2026
Cite this page
510(k) Report. “K012017: Variseed 7.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012017
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026