# K260584: BoneMRI

- Pathway: 510(k) (Traditional)
- Applicant: Mriguidance B.V.
- Decided: Aug 21, 2026 after 182 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: 9 generations back to K922470 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233030: BoneMRI, Mriguidance B.V. (2024) Summary page 5.

## 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 increased contrast with respect to the surrounding soft tissue in BoneMRI images and to visualize the T1w contrast in Synthetic T1w images. It is to be used in the pelvic region, which includes the bony anatomy of the sacrum, hip bones and femoral heads; and the spine, which includes the bony anatomy of the cervical, thoracic, lumbar, and S1 vertebrae. BoneMRI is indicated for use in patients 12 years and older. Synthetic T1w is indicated for use in patients 18 years and older. BoneMRI is not to be used for diagnosis or monitoring of (primary or metastatic) tumors. BoneMRI images are not intended to replace CT images in general but can be used to visualize 3D bone morphology, tissue radiodensity and tissue radiodensity contrast.

Source page: https://510kreport.com/device/K260584
Methodology: https://510kreport.com/methodology