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FDA 510(k)

VBrain

K-Number: K203235 · 2021-03-19

ApplicantVysioneer, Inc.
Decision Date2021-03-19
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VBrain is a medical device manufactured by Vysioneer, Inc.. It received FDA 510(k) clearance on 2021-03-19 under approval number K203235. 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?

VBrain is a medical device that received FDA 510(k) clearance on 2021-03-19. It is manufactured by Vysioneer, Inc.. The 510(k) number is K203235.

When was VBrain approved by the FDA?

VBrain received FDA 510(k) clearance on 2021-03-19, under approval number K203235.

What company makes VBrain?

VBrain is manufactured by Vysioneer, Inc..

What is the FDA product code for VBrain?

The FDA product code for VBrain is QKB.

Other Devices by Vysioneer, Inc.

K213628VBrain K212116VBrain-OAR

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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