510(k) · Cleared
Recalled · 2012Varisource IX 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 16, 2007 as substantially equivalent to K061582 (Varian Medical Systems, Inc., 2006) after a 48-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Jul 16, 2007
- Review
- 48 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945383 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK945383 High Dose Rate AfterloaderVarian Assoc., Inc. · 1995
- 1 generation backK061582 Varisource 200 HDR AfterloaderVarian Medical Systems, Inc. · 2006
- This deviceK071467 Varisource IX HDR AfterloaderVarian Medical Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK122236 Varisourse IX Brahytherapy Afterloader Varisource IX (T)…Varian Medical Systems, Inc. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122236Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy AfterloaderVarian Medical Systems, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945383 | High Dose Rate Afterloader | Varian Assoc., Inc. | 1995 | — |
| −1 | K061582 | Varisource 200 HDR Afterloader | Varian Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K071467 | Varisource IX HDR Afterloader | Varian Medical Systems, Inc. | 2007 | — |
| +1 | K122236 | Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy… | Varian Medical Systems, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K061582 | Varisource 200 HDR AfterloaderSummary page 1…R §892.5700 Class 11 Product Code: JAQ 3. Predicate Device to claim substantial equivalence: VariSource K061582 4. Description of the Device: The VaniSource iX Series High Dose Rate Afterloader system is a computer controlled rem… | 2006 |
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 |
|---|---|---|---|
| K122236 | Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy Afterloader | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2012 | Not classified | Z-1200-2012 | Device Design | Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients. |
| Jan 5, 2012 | Not classified | Z-1199-2012 | Device Design | Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients. |
| Mar 1, 2010 | Not classified | Z-0325-2012 | Software design | VariSource iX console software may cause incorrect dwell times to be delivered to patient and may result in a mistreatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122236 (Varian Medical Systems, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K061582.
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. 2007, 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 VariSource iX is indicated, in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled high dose-rate Brachytherapy for conditions anywhere in the body when brachytherapy treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071467: Varisource IX 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/K071467
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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