# K891131: Gammamed 12I

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Aug 7, 1989 after 157 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030745: Gammamed 212 and 232 Source Assembly (2003), 7 descendants of its own
- K042864: Implant Sciences Corp, Model HDR-4140 (2005), 4 descendants of its own
- K090366: Spec Model M-31 (2009), 1 descendant of its own
- K063815: Varian Esophagus Bougie Applicator (2007), 1 descendant of its own
- K052947: Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy Source (2006), 1 descendant of its own

## Recalls of this device
- Oct 6, 2011 · Not classified · Z-0329-2012: The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
- Oct 6, 2011 · Not classified · Z-0330-2012: The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
- Sep 11, 2006 · Not classified · Z-0486-2007: Medical device for patient treatment does not meet electrical safety standards.
- May 1, 2006 · Not classified · Z-1398-06: Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the t

Source page: https://510kreport.com/device/K891131
Methodology: https://510kreport.com/methodology