FDA 510(k)

Surgical Reality Viewer

Número K: K252091 · 2026-01-29

Data da decisão2026-01-29

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Reality Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Medicalvr B.V.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K252091. 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 Surgical Reality Viewer?

Surgical Reality Viewer is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Medicalvr B.V.. The 510(k) number is K252091.

When did Surgical Reality Viewer receive FDA 510(k) clearance?

Surgical Reality Viewer received FDA 510(k) clearance on 2026-01-29, under 510(k) number K252091.

Who is the listed applicant for Surgical Reality Viewer?

The FDA 510(k) record lists Medicalvr B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Reality Viewer?

The FDA product code for Surgical Reality Viewer is QIH.

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