Elucid FFR-IQ (B.1)— 510(k) K262015
Substantially EquivalentElucid Bioimaging, Inc.
FDA 510(k) clearance K262015 for Elucid FFR-IQ (B.1), Substantially Equivalent on 2026-09-29. Applicant: Elucid Bioimaging, Inc.. Device class: 2.
Summary
Elucid FFR-IQ (version B.1) is coronary physiology software filed under PJA, coronary vascular physiologic simulation software. That code covers software meant to aid in identifying functionally significant cardiovascular disease. The record doesn't describe the inputs or outputs for this version.
Class II, 21 CFR 870.1415, Cardiovascular panel, Traditional 510(k).
Elucid Bioimaging, Inc. filed from Boston, Massachusetts. Review took 106 days (June 15 to September 29, 2026).
Clearance details
- Applicant
- Elucid Bioimaging, Inc.
- Product code
- Product code PJA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1415
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code PJA
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