# K202404: BoneMRI

- Pathway: 510(k) (Traditional)
- Applicant: Mriguidance B.V.
- Decided: Dec 22, 2021 after 488 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K922470 (1992). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191688: SubtleMR, Subtle Medical, Inc. (2019) Summary page 5.

## Most influential descendants
- K221762: BoneMRI v1.4 (2022), 4 descendants of its own
- K230197: BoneMRI v1.6 (2023), 3 descendants of its own
- K233030: BoneMRI (2024), 2 descendants of its own
- K260525: NextMR Spine (2026), 0 descendants of its own
- K260584: BoneMRI (2026), 0 descendants of its own

## Indications for use
BoneMRI is an image processing software that can be used for image enhancement in MRI images. It can be used to visualize the bone structures in MRI images with enhanced contrast with respect to the surrounding soft tissue. It is to be used in the pelvic region, which includes the boney anatomy of the sacrum, hip bones and femoral heads. Warning: BoneMRI images are not intended to replace CT images and are not to be used for diagnosis or monitoring of (primary or metastatic) tumors.

Source page: https://510kreport.com/device/K202404
Methodology: https://510kreport.com/methodology