# K040541: Mammosource High Dose Rate (HDR) Remote Afterloader

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 22, 2004 after 20 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K912555 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System, Gammamed USA (1998) Summary page 1.

## Recalls of this device
- May 1, 2006 · Not classified · Z-1270-06: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K040541
Methodology: https://510kreport.com/methodology