510(k) · Cleared
Recalled · 2012Variseed 7.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · KXK Source, Brachytherapy, Radionuclide
Cleared on May 21, 2003 as substantially equivalent to K982821 (Multimedia Medical Systems, Inc., 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1993. 83 later devices descend from it. It has been recalled once.
- Decided
- May 21, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- KXK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924240 (1993). 4 ancestors in all. 83 later devices descend from it, 3 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 deviceK030534 Variseed 7.1Varian Medical Systems · 2003
- Descendant · cites it directly · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- Descendant · 2 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- Descendant · 2 generations on · 67 of its ownK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- Descendant · 3 generations on · 54 of its ownK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- Descendant · 3 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · cites it directly79descendants
- K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 2 generations on68descendants
- K172218MIM – Y90 DosimetryMim Software, Inc. · 2017 · 2 generations on67descendants
- K180815MIM - SPECTRA QuantMim Software, Inc. · 2018 · 3 generations on54descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 3 generations on53descendants
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) | K030534 | Variseed 7.1 | Varian Medical Systems | 2003 | — |
| +1 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| +2 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| +2 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| +3 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| +3 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 10 | 0 |
| 2022 | 8 | 0 |
| 2023 | 11 | 0 |
| 2024 | 9 | 0 |
| 2025 | 11 | 0 |
| 2026 | 11 | 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 KXK? 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 KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 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 2…Characteristics: The VariSeed 7.1 treatment planning system is substantially equivalent to the brachytherapy functions of the Varian Medical Systems, Inc. VariSeed 7.0 (K982821) and Varian Medical System, Inc. BrachyVision 6.0 (K992762) treatment planning systems. The table below compares the feature set… | 1998 |
| * | K992762 | Brachyvision 6.0Summary page 1…[email protected] Device Name: VariSeed 7.1 Classification Name: Source, Brachytherapy, Radionuclide Predicate Device: VariSeed 7.0 (K98282 l), BrachyVision 6.0 (K992762) Product Description: VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy p… | 2000 |
What descends from it? (83)
See all 833 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 |
|---|---|---|---|---|
| Jan 25, 2012 | Not classified | Z-1385-2012 | Labeling design | Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 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, K103576 (Mim Software, Inc., 2011) has gone furthest, with 79 descendants of its own.
- 2 other devices also cite its predicate K982821.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, 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 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VariSeed 7.1 is a software application for planning and evaluating brachytherapy
procedures for the treatment of prostate cancer 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 as stated in the FDA summary.
https://510kreport.com/device/K030534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030534: Variseed 7.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030534
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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