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Spinal Frontiers · Regulatory Watch · FDA decision

AI software that builds CT-like spine bone images from MRI cleared

FDA decision · MRI2CT

4 September 2026

MRI2CT announced 510(k) clearance for NextMR, software that generates CT-like 3D bone views of the spine from standard MRI. The FDA record number is not yet listed.

Type
FDA decision
Company
MRI2CT
Device
NextMR
Date
4 September 2026
Jurisdiction
US
Classification
510(k) K260525 (FDA decision 4 Sep 2026; announced 7 Oct 2026)
Source
SPINEMarketGroup (company announcement)

Official source →Source checked

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