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510(k) clearances

Elucid FFR-IQ (B.1)

Elucid Bioimaging, Inc. · Cardiovascular

K262015Substantially EquivalentTraditionalPJA
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Third party flag
N
City
Boston
Advisory committee description
Cardiovascular
Address 1
399 Boylston St., Suite 400
Statement or summary
Summary
Product code
PJA
Zip code
02116
Applicant
Elucid Bioimaging, Inc.
Decision date
2026-09-29
Decision code
SESE
Country code
US
Device name
Elucid FFR-IQ (B.1)
Advisory committee
CV
Contact
Windi Hary
K number
K262015
State
MA
Date received
2026-06-15
Review advisory committee
CV
Postal code
02116
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Coronary Vascular Physiologic Simulation Software
Medical specialty description
Cardiovascular
Regulation number
870.1415
Device class
2
Registration number
3021637148, 3025430791
FEI number
3021637148, 3025430791
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.