FDA 510(k)

Elucid PlaqueIQ

K-Number: K241524 · 2024-09-12

Decision Date2024-09-12

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Elucid PlaqueIQ is the device name listed in this FDA 510(k) record. The listed applicant is Elucid Bioimaging, Inc.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K241524. 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 Elucid PlaqueIQ?

Elucid PlaqueIQ is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Elucid Bioimaging, Inc.. The 510(k) number is K241524.

When did Elucid PlaqueIQ receive FDA 510(k) clearance?

Elucid PlaqueIQ received FDA 510(k) clearance on 2024-09-12, under 510(k) number K241524.

Who is the listed applicant for Elucid PlaqueIQ?

The FDA 510(k) record lists Elucid Bioimaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elucid PlaqueIQ?

The FDA product code for Elucid PlaqueIQ is LLZ.

Other records listing Elucid Bioimaging, Inc. as applicant

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.