# K250299: CT/ MR Tandem and Ovoid Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: May 9, 2025 after 98 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: 4 generations back to K871217 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241853: Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve, Varian Medical Systems, Inc. (2024) Summary page 5.

## Indications for use
The CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy.

Source page: https://510kreport.com/device/K250299
Methodology: https://510kreport.com/methodology