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FDA 510(k)

Elucid FFR-IQ (B.1)

K-Number: K262015 · 2026-09-29

ApplicantElucid Bioimaging, Inc.
Decision Date2026-09-29
Product CodePJA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Elucid FFR-IQ (B.1) 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 2026-09-29 under 510(k) number K262015. The device is classified under product code PJA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elucid FFR-IQ (B.1)?

Elucid FFR-IQ (B.1) is a medical device that received FDA 510(k) clearance on 2026-09-29. The listed applicant is Elucid Bioimaging, Inc.. The 510(k) number is K262015.

When did Elucid FFR-IQ (B.1) receive FDA 510(k) clearance?

Elucid FFR-IQ (B.1) received FDA 510(k) clearance on 2026-09-29, under 510(k) number K262015.

Who is the listed applicant for Elucid FFR-IQ (B.1)?

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 FFR-IQ (B.1)?

The FDA product code for Elucid FFR-IQ (B.1) is PJA.

Related Clinical Trials

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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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.

K261855Elucid PlaqueIQK241524Elucid PlaqueIQK221463ElucidVivo A.3K183012vascuCAPK163071vascuCAP

Related Devices (Code: PJA)

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.

K250902HeartFlow AnalysisHeartFlow, Inc.K213857HeartFlow AnalysisHeartFlow, Inc.K213657DEEPVESSEL FFRKeyamed Na, Inc.K203329HeartFlow AnalysisHeartFlow, Inc.K190925HeartFlow FFRct AnalysisHeartFlow, Inc.K182035FFRctHeartFlow, 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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