# K983436: Gammamed Plus High Dose Rate Remote Afterloading System

- Pathway: 510(k) (Special)
- Applicant: Gammamed USA
- Decided: Oct 29, 1998 after 30 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912555 (1991). 1 ancestor in all.
55 later devices descend from it; 13 cite 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)
- K912555: Gammamed 12IT High Dose Rate Remote Afterloader, Rts Technology, Inc. (1991) Summary page 1.

## Most influential descendants
- 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
- K091378: Mammosite II Radiation Therapy System (2009), 9 descendants of its own

## Recalls of this device
- Sep 28, 2012 · Class II · Z-0607-2013: The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
- Jul 13, 2011 · Not classified · Z-2998-2011: Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
- Jul 13, 2011 · Not classified · Z-3000-2011: Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
- Jul 13, 2011 · Not classified · Z-2995-2011: Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
- Jul 13, 2011 · Not classified · Z-2992-2011: Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.
- Jul 13, 2011 · Not classified · Z-2999-2011: Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
- Jul 13, 2011 · Not classified · Z-3013-2011: Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
- Jul 13, 2011 · Not classified · Z-2993-2011: Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.
- Jul 13, 2011 · Not classified · Z-2991-2011: Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.
- Jul 13, 2011 · Not classified · Z-2996-2011: Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
- Jul 13, 2011 · Not classified · Z-2997-2011: Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.
- Sep 30, 2008 · Not classified · Z-0326-2012: Plastic needle tip could possibly crack or separate.
- Sep 30, 2008 · Not classified · Z-0328-2012: Plastic needle tip could possibly crack or separate.
- Sep 30, 2008 · Not classified · Z-0327-2012: Plastic needle tip could possibly crack or separate.
- Aug 5, 2008 · Not classified · Z-0295-2012: GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
- May 1, 2006 · Not classified · Z-1268-06: 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
- Apr 14, 2005 · Not classified · Z-0921-05: A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.

## Indications for use
The intended use of the GammaMed Plus transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.

Source page: https://510kreport.com/device/K983436
Methodology: https://510kreport.com/methodology