# K031524: Gammamed Plus 3/24 HDR Remote Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Nov 26, 2003 after 195 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.
7 later devices descend from it; 2 cite it directly.
0 of 10 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.

## Most influential descendants
- K071381: Gammamedplus IX Series HDR Afterloader (2007), 5 descendants of its own
- K120993: Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy Afterloader (2012), 4 descendants of its own
- K181903: BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device (2018), 2 descendants of its own
- K191580: BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device (2019), 1 descendant of its own
- K221797: BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device (2022), 0 descendants of its own

## Recalls of this device
- May 1, 2006 · Not classified · Z-1269-06: 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
The GammaMedphs 3/24 is a remotely controlled afterloading brachytherapy device used to apply a radionuclide source into the body or to the surface of the body for radiation therapy. The system is designed to provide a predetermined dose of radiation to tissue and organs by means of manipulating a radioactive source from a shielded position within in the device into a catheter, applicator, or needle, which has been placed within or on a patient. The remote afterloading device must be contained in a shielded facility during extension of the radioactive source. The GammaMedplus 3/24 may optionally be configured as a transportable device.

Source page: https://510kreport.com/device/K031524
Methodology: https://510kreport.com/methodology