FDA De Novo (DEN130045) HeartFlow FFRCT v1.4

Device Name: HeartFlow FFRCT v1.4

Regulation Number: 21 CFR 870.1415

Regulation Name: Coronary Artery Disease (CAD) Analysis Software for Clinical Use

Product Code: PJA

Device Class: Class II (Special Controls), Prescription Use

Decision Date: November 26, 2014

De Novo Number: DEN130045

Applicant: HeartFlow, Inc., Redwood City, CA

Total pages: 658
Fully redacted pages: 642
Content pages: 16