# K193109: MRCAT brain

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems MR Finland
- Decided: Jan 24, 2020 after 77 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: 11 generations back to K010975 (2001). 33 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182888: MRCAT Pelvis, Philips Medical Systems MR Finland (2019) Summary page 5.

## Most influential descendants
- K211841: MRI Planner (2022), 0 descendants of its own
- K214081: MRCAT Head & Neck (2022), 0 descendants of its own

## Indications for use
MRCAT Brain is a software add-on for Ingenia, Ingenia Ambition, and Ingenia Elition MR systems. Intended 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. Indications for use: MRCAT brain is indicated for radiotherapy treatment planning for primary and metastatic brain tumor patients.

Source page: https://510kreport.com/device/K193109
Methodology: https://510kreport.com/methodology