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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 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.

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. 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.

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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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