# K214081: MRCAT Head & Neck

- Pathway: 510(k) (Traditional)
- Applicant: Philips OY
- Decided: Apr 5, 2022 after 99 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010975 (2001). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193109: MRCAT brain, Philips Medical Systems MR Finland (2020) Summary page 5.

## Indications for use
MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning. MRCAT Head and Neck is indicated for radiotherapy treatment planning for patients with soft tissue tumors in the Head and Neck region.

Source page: https://510kreport.com/device/K214081
Methodology: https://510kreport.com/methodology