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FDA 510(k)

BU-CAD

K-Number: K210670 · 2021-12-21

ApplicantTaihao Medical, Inc.
Decision Date2021-12-21
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BU-CAD is a medical device manufactured by Taihao Medical, Inc.. It received FDA 510(k) clearance on 2021-12-21 under approval number K210670. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BU-CAD?

BU-CAD is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Taihao Medical, Inc.. The 510(k) number is K210670.

When was BU-CAD approved by the FDA?

BU-CAD received FDA 510(k) clearance on 2021-12-21, under approval number K210670.

What company makes BU-CAD?

BU-CAD is manufactured by Taihao Medical, Inc..

What is the FDA product code for BU-CAD?

The FDA product code for BU-CAD is QDQ.

Other Devices by Taihao Medical, Inc.

K151075BR-ABVS Viewer 1.0 K171709BR-FHUS Viewer 1.0 K171309BR-FHUS Navigation 1.0

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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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