# K260525: NextMR Spine

- Pathway: 510(k) (Traditional)
- Applicant: MRI2CT, Inc.
- Decided: Sep 4, 2026 after 199 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 6.

## Indications for use
MRI2CT NextMR Spine is an image processing software that can be used for image enhancement in MRI images. It can be used to visualize the 3D bone morphology in MRI images. It is to be used in the lumbar spine vertebrae (L1-L5) and the sacrum. MRI2CT NextMR Spine is indicated for use in patients 18 years and older. MRI2CT NextMR Spine images are not intended to replace CT images in general. MRI2CT NextMR Spine is not to be used for diagnosis or monitoring of (primary or metastatic) tumors or provide a quantitative bone mineral density diagnosis or bone quality assessment.

Source page: https://510kreport.com/device/K260525
Methodology: https://510kreport.com/methodology