510(k) · Cleared
Recalled · 2006Mammosource High Dose Rate (HDR) Remote 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 Mar 22, 2004 as substantially equivalent to K983436 (Gammamed USA, 1998) after a 20-day review. Its family tree reaches back 2 generations to 1991. It has been recalled once.
- Decided
- Mar 22, 2004
- Review
- 20 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912555 (1991). No later device cites it as a predicate yet.
- Root · 2 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 1 generation backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- This deviceK040541 Mammosource High Dose Rate (HDR) Remote AfterloaderVarian Medical Systems, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −1 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| 0 (this device) | K040541 | Mammosource High Dose Rate (HDR) Remote Afterloader | Varian Medical Systems, Inc. | 2004 | — |
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 |
|---|---|---|---|
| * | K983436 | Gammamed Plus High Dose Rate Remote Afterloading SystemSummary page 1…urce HDR Remote Afterloader Proprietary Name: MammoSource HDR Remote Afterloader 3. Predicate Device: GamnmaMed plus HDR Remote Afterloader, K983436 4. Device Description: The GammaMed Plus device has been modified to reduce the number of channels from 24 channels t… | 1998 |
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 1, 2006 | Not classified | Z-1270-06 | Other | Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 12 other devices also cite its predicate K983436.
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?
MamrrioSource is indicated for high-dose-rate remotely controlled afterloading brachytherapy for the treatment of breast cancer and other cancers that can be treated with a single channel HDR system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040541: Mammosource High Dose Rate (HDR) Remote Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040541
Report an extraction error
Are you the manufacturer?
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