# K030745: Gammamed 212 and 232 Source Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Mar 12, 2003 after 2 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891131 (1989). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891131: Gammamed 12I, Mick Radio-Nuclear Instruments, Inc. (1989) Summary page 1.

## Most influential descendants
- K042864: Implant Sciences Corp, Model HDR-4140 (2005), 4 descendants of its own
- K090366: Spec Model M-31 (2009), 1 descendant of its own
- K052947: Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy Source (2006), 1 descendant of its own
- K161396: SPEC Model M23 (2016), 0 descendants of its own
- K141038: Ant Model 1 (2014), 0 descendants of its own

## Indications for use
The Gammamed Model 212 and 232 source assembly is designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors.

Source page: https://510kreport.com/device/K030745
Methodology: https://510kreport.com/methodology