BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    THE IC-PRO SYSTEM, MODEL VERSION 3.2

    K Number: K083745 · Decision Feb 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    8
    Review Days
    63

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    THE IC-PRO SYSTEM, MODEL VERSION 3.2
    K Number
    K083745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paieon, Inc.
    Date Received
    December 16, 2008
    Decision Date
    February 17, 2009
    Product Code
    IZI
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZI System, X-Ray, Angiographic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IZI), ordered by most recent decision date.

    780 nm SPY Portable Handheld Imaging (SPY-PHI) System

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURGIMAGE SIM 1000H Fluorescence Imaging Platform

    FDA 510(k)
    FDA Class 2 ·Radiology

    IC-Flow™ Imaging System 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Affirm 800

    FDA 510(k)
    FDA Class 2 ·Radiology

    Modus IR

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Paieon, Inc.

    K Number Device Name
    K120282 CARDNAV
    K113594 C-THV SYSTEM
    K110256 THE IC-PRO SYSTEM
    K082907 IC-PRO SYSTEM, VERSION 3.1.0.4
    K073328 CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
    K072591 CARDIOP-B SYSTEM, VERSION 2.1
    K030139 THE CARDIOP-B SYSTEM