510(k) · Cleared
ClearedVarisource 200 HDR Afterloader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jul 25, 2006 as substantially equivalent to K945383 (Varian Assoc., Inc., 1995) after a 48-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it.
- Decided
- Jul 25, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945383 (1995). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK945383 High Dose Rate AfterloaderVarian Assoc., Inc. · 1995
- This deviceK061582 Varisource 200 HDR AfterloaderVarian Medical Systems, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK122951 Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK153570 Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK132092 EsteyaNucletron B.V. · 2013
- Descendant · cites it directly · 1 of its ownK071467 Varisource IX HDR AfterloaderVarian Medical Systems, Inc. · 2007 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072683Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008 · cites it directly5descendants
- K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013 · cites it directly4descendants
- K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016 · 2 generations on1descendant
- K132092EsteyaNucletron B.V. · 2013 · 2 generations on1descendant
- K071467Varisource IX HDR AfterloaderVarian Medical Systems, Inc. · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945383 | High Dose Rate Afterloader | Varian Assoc., Inc. | 1995 | — |
| 0 (this device) | K061582 | Varisource 200 HDR Afterloader | Varian Medical Systems, Inc. | 2006 | — |
| +1 | K072683 | Axxent Electronic Brachytherapy System | Xoft, Inc. | 2008 | — |
| +1 | K122951 | Xoft Axxent Electronic Brachytherapy System Model 110 | Icad, Inc. | 2013 | — |
| +2 | K153570 | Axxent Electronic Brachytherapy System Model 110 XP 1200 | Icad, Inc. | 2016 | — |
| +2 | K132092 | Esteya | Nucletron B.V. | 2013 | — |
| +1 | K071467 | Varisource IX HDR Afterloader | Varian Medical Systems, Inc. | 2007 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 JAQ? 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 JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 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 |
|---|---|---|---|
| * | K945383 | High Dose Rate AfterloaderSummary page 3…tion as known to Varian from a review of published information available about competing products and the predicate device. 510(k) Number K945383 Intended Use High Dose Rate High Dose Rate… | 1995 |
What descends from it? (8)
3 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 JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, 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 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The VariSource 200 System is a High Dose Rate Brachytherapy Afterloader used to treat
lesions, tumors and conditions in the body where radiation is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061582: Varisource 200 HDR Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061582
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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