FDA 510(k)

NextMR Spine

Número K: K260525 · 2026-09-04

Data da decisão2026-09-04

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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