# K241764: Mould Probe MR Safe

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jan 10, 2025 after 204 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.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162615: Mould Applicator Set, Varian Medical Systems, Inc. (2017) Summary page 5.

## Indications for use
The Mould Probe MR Safe is intended for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy. IORT - Intraoperative Radiation Therapy

Source page: https://510kreport.com/device/K241764
Methodology: https://510kreport.com/methodology