510(k) · Cleared
Recalled · Class II · 2015Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy 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 Nov 16, 2012 as substantially equivalent to K071467 (Varian Medical Systems, Inc., 2007) after a 113-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- Nov 16, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945383 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK945383 High Dose Rate AfterloaderVarian Assoc., Inc. · 1995
- 2 generations backK061582 Varisource 200 HDR AfterloaderVarian Medical Systems, Inc. · 2006
- 1 generation backK071467 Varisource IX HDR AfterloaderVarian Medical Systems, Inc. · 2007 · Recalled
- This deviceK122236 Varisourse IX Brahytherapy Afterloader Varisource IX (T)…Varian Medical Systems, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945383 | High Dose Rate Afterloader | Varian Assoc., Inc. | 1995 | — |
| −2 | K061582 | Varisource 200 HDR Afterloader | Varian Medical Systems, Inc. | 2006 | — |
| −1 | K071467 | Varisource IX HDR Afterloader | Varian Medical Systems, Inc. | 2007 | 3 |
| 0 (this device) | K122236 | Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy… | Varian Medical Systems, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K071467 | Varisource IX HDR AfterloaderSummary page 1…aders, Variource iXseries afterloader systems, Variource D(Series Predicate Device: Variource iXHDR Afterloader (K071467) Device Description: The Variource D(series afterloader systems are computer… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2015 | Class II | Z-1849-2015 | Software Design Change | After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with magnetic Hard Disk… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2012, this device’s year, is highlighted.
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 Variource iX and Variource iX(t) are indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122236: Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122236
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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