# K222775: Aarhus Applicator Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Mar 13, 2023 after 180 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: 5 generations back to K864210 (1986). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150839: 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90, Varian Medical Systems, Inc. (2015) Summary page 4.

## Most influential descendants
- K252884: Guided Aarhus Applicator Set (2025), 0 descendants of its own

## Indications for use
The Aarhus Applicator Set is indicated for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy within a hospital CT or MRI environment.

Source page: https://510kreport.com/device/K222775
Methodology: https://510kreport.com/methodology