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FDA 510(k)

Surgical Reality Viewer

K-Number: K252091 · 2026-01-29

ApplicantMedicalvr B.V.
Decision Date2026-01-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Surgical Reality Viewer is a medical device manufactured by Medicalvr B.V.. It received FDA 510(k) clearance on 2026-01-29 under approval number K252091. 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 Surgical Reality Viewer?

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

When was Surgical Reality Viewer approved by the FDA?

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

What company makes Surgical Reality Viewer?

Surgical Reality Viewer is manufactured by Medicalvr B.V..

What is the FDA product code for Surgical Reality Viewer?

The FDA product code for Surgical Reality Viewer is QIH.

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Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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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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