# K250289: Intracavitary/Interstitial System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Apr 25, 2025 after 84 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201272: Geneva, Nucletron B.V. (2020) Summary page 5.

## Indications for use
The Intracavitary/ Interstitial System is intended for cancer treatment of the uterus, cervix, and vagina using HDR or PDR brachytherapy.

Source page: https://510kreport.com/device/K250289
Methodology: https://510kreport.com/methodology