Cleared Traditional

K262015 - Elucid FFR-IQ (B.1)

K262015 is an FDA 510(k) clearance for Elucid FFR-IQ (B.1), manufactured by Elucid Bioimaging, Inc.. The device is a Class 2 Cardiovascular device with product code PJA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K262015 · Elucid Bioimaging, Inc. · Cardiovascular device
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Sep 2026
Decision
106d
Days
Class 2
Risk

K262015 is an FDA 510(k) clearance for the Elucid FFR-IQ (B.1). Classified as Coronary Vascular Physiologic Simulation Software (product code PJA), Class II - Special Controls.

Submitted by Elucid Bioimaging, Inc. (Boston, US). The FDA issued a Cleared decision on September 29, 2026 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1415 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Elucid Bioimaging, Inc. devices

FDA 510(k) Submission Details - K262015

510(k) Number K262015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2026
Decision Date September 29, 2026
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PJA Device Classification - Class 2, Special Controls

Product Code PJA Coronary Vascular Physiologic Simulation Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1415
Definition A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PJA Coronary Vascular Physiologic Simulation Software

All 9
Devices cleared under the same product code (PJA) and FDA review panel - the closest regulatory comparables to K262015.
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HeartFlow Analysis
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HeartFlow FFRct Analysis
K190925 · HeartFlow, Inc. · Aug 2019
FFRct
K182035 · HeartFlow, Inc. · Dec 2018