510(k) clearance
Elucid FFR-IQ (B.1)
- 510(k) number
- K262015
- Applicant
- Elucid Bioimaging, Inc.
- Decision date
- Sep 29, 2026
- Date received
- Jun 15, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PJA
- Device type
- Coronary Vascular Physiologic Simulation Software
- Device class
- Class II
- Regulation
- 21 CFR 870.1415
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Boston, MA, US