NextMR Spine— 510(k) K260525

Name: FDA 510(k) clearance K260525
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Substantially Equivalent

MRI2CT, Inc.

FDA 510(k) clearance K260525 for NextMR Spine, Substantially Equivalent on 2026-09-04. Applicant: MRI2CT, Inc.. Device class: 2.

Summary

NextMR Spine from MRI2CT is filed under QIH, automated radiological image processing software. The name points to spine MR images, but the record doesn't describe the processing it performs or its outputs.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

MRI2CT filed from Claymont, Delaware. Review took 199 calendar days (February 17 to September 4, 2026).

Clearance details

Applicant: MRI2CT, Inc.
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-02-17
Decision date: 2026-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claymont, DE, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.