# K071381: Gammamedplus IX Series HDR Afterloader

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Jul 18, 2007 after 62 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912555 (1991). 3 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K983436: Gammamed Plus High Dose Rate Remote Afterloading System, Gammamed USA (1998) Summary page 1.
- K031524: Gammamed Plus 3/24 HDR Remote Afterloader, Varian Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K142986: SagiNova (2015), 0 descendants of its own

## Indications for use
Both the GammaMedplus iX and GammaMedplus 3/24 iX are indicated, in the treatment benign and malignant disease, for both curative and palliative intent, in the delivery of both controlled high dose rate brachytherapy of remote for conditions anywhere in the body when brachytherapy treatment is indicated.

Source page: https://510kreport.com/device/K071381
Methodology: https://510kreport.com/methodology