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FDA 510(k)

VBrain-OAR

K-Number: K212116 · 2021-10-12

ApplicantVysioneer, Inc.
Decision Date2021-10-12
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VBrain-OAR is a medical device manufactured by Vysioneer, Inc.. It received FDA 510(k) clearance on 2021-10-12 under approval number K212116. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VBrain-OAR?

VBrain-OAR is a medical device that received FDA 510(k) clearance on 2021-10-12. It is manufactured by Vysioneer, Inc.. The 510(k) number is K212116.

When was VBrain-OAR approved by the FDA?

VBrain-OAR received FDA 510(k) clearance on 2021-10-12, under approval number K212116.

What company makes VBrain-OAR?

VBrain-OAR is manufactured by Vysioneer, Inc..

What is the FDA product code for VBrain-OAR?

The FDA product code for VBrain-OAR is QKB.

Other Devices by Vysioneer, Inc.

K213628VBrain K203235VBrain

Related Devices (Code: QKB)

K181572Workflow BoxMirada Medical, Ltd. K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. K200323AutoContourRadformation, Inc. K193252Contour ProtegeAIMim Software, Inc. K191928AccuContourXiamen Manteia Technology , Ltd. K213628VBrainVysioneer, 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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