# K211841: MRI Planner

- Pathway: 510(k) (Traditional)
- Applicant: Spectronic Medical AB
- Decided: Aug 25, 2022 after 437 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 4.

## Indications for use
MRI Planner is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to process images from MRI systems to 1) provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning, and to 2) derive contours for input to radiation treatment planning by assisting in localization and definition of healthy anatomical structures. MRI Planner is not intended to automatically contour tumors or tumor clinical target volumes. MRI Planner is indicated for radiotherapy planning of adult patients for primary and metastatic cancers in the brain and head-neck regions, as well as soft tissue cancers in the pelvic region. MRI Planner generates synthetic CT images for radiation attenuation estimation purposes for the pelvis, brain and head-neck regions only. MRI Planner generates automatically derived contours of the bladder, colon and femoral heads, for prostate cancer patients only.

Source page: https://510kreport.com/device/K211841
Methodology: https://510kreport.com/methodology