# K912555: Gammamed 12IT High Dose Rate Remote Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Rts Technology, Inc.
- Decided: Aug 2, 1991 after 52 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
56 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System (1998), 55 descendants of its own
- K033371: Varian Intracavitary Brachytherapy Applicators (2003), 29 descendants of its own
- K070659: Biolucent Applicator Kit (2007), 13 descendants of its own
- K080565: Modification to: Savi Applicator Kit (2008), 12 descendants of its own
- K081677: Savi Applicator Kit (2008), 11 descendants of its own

## Recalls of this device
- 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-1399-06: 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/K912555
Methodology: https://510kreport.com/methodology