# K162615: Mould Applicator Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 24, 2017 after 186 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: 2 generations back to K912555 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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 4.

## Most influential descendants
- K241764: Mould Probe MR Safe (2025), 0 descendants of its own

## Indications for use
The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy.

Source page: https://510kreport.com/device/K162615
Methodology: https://510kreport.com/methodology