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FDA 510(k)

ElucidVivo A.3

K-Number: K221463 · 2022-06-17

ApplicantElucid Bioimaging, Inc.
Decision Date2022-06-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ElucidVivo A.3 is a medical device manufactured by Elucid Bioimaging, Inc.. It received FDA 510(k) clearance on 2022-06-17 under approval number K221463. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ElucidVivo A.3?

ElucidVivo A.3 is a medical device that received FDA 510(k) clearance on 2022-06-17. It is manufactured by Elucid Bioimaging, Inc.. The 510(k) number is K221463.

When was ElucidVivo A.3 approved by the FDA?

ElucidVivo A.3 received FDA 510(k) clearance on 2022-06-17, under approval number K221463.

What company makes ElucidVivo A.3?

ElucidVivo A.3 is manufactured by Elucid Bioimaging, Inc..

What is the FDA product code for ElucidVivo A.3?

The FDA product code for ElucidVivo A.3 is LLZ.

Other Devices by Elucid Bioimaging, Inc.

K163071vascuCAP K183012vascuCAP K241524Elucid PlaqueIQ

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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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