BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    BCM 400CP

    K Number: K946378 · Decision May 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    198
    Applicant Total
    8
    Review Days
    132

    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
    BCM 400CP
    K Number
    K946378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1600
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    B C Medical , Ltd.
    Date Received
    December 23, 1994
    Decision Date
    May 4, 1995
    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 B C Medical , Ltd.

    K Number Device Name
    K933100 ARC-600
    K933035 BCM-600TX
    K920862 BCM-400C
    K890306 BCM-ARC 105 X-RAY MOBILE UNIT
    K870205 ROTAX-II BI-PLANE CIRCULAR ARM
    K801949 BCM-302 COLLIMATING CONE & COMPENSATIN
    K801950 BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO