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FDA 510(k)

NextMR Spine

K-Number: K260525 · 2026-09-04

ApplicantMRI2CT, Inc.
Decision Date2026-09-04
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NextMR Spine is the device name listed in this FDA 510(k) record. The listed applicant is MRI2CT, Inc.. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K260525. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NextMR Spine?

NextMR Spine is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is MRI2CT, Inc.. The 510(k) number is K260525.

When did NextMR Spine receive FDA 510(k) clearance?

NextMR Spine received FDA 510(k) clearance on 2026-09-04, under 510(k) number K260525.

Who is the listed applicant for NextMR Spine?

The FDA 510(k) record lists MRI2CT, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextMR Spine?

The FDA product code for NextMR Spine is QIH.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260811Heartvue.ProtonHeartvue.ai, Inc.K261595Ceevra Reveal 4Ceevra, Inc.K262127DS Core CBCT AnatomyDentsply SironaK260584BoneMRIMriguidance B.V.K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.K253794Prostate CoreLucida Medical, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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