BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEARTFLOW, INC.

    Reg #: 3021637148 · FEI: 3021637148 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    HEARTFLOW, INC.
    Registration Number
    3021637148
    FEI Number
    3021637148
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    135 Main St Ste 1000
    City
    San Francisco
    State
    CA
    ZIP
    94105
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203329

    Owner / Operator

    Firm Name
    HeartFlow, Inc.
    Operator Number
    10048116
    Address
    135 Main St Ste 1000
    City
    San Francisco
    State
    CA
    Postal Code
    94105
    Country
    US
    Correspondent
    Mazi Kiani

    Products

    Device Name Product Code
    Coronary Vascular Physiologic Simulation Software PJA
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    HeartFlow FFRCT Analysis Heartflow Analysis

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility