BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DC-1 CARDIAC IMAGING MODULE

    K Number: K811556 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    42
    Review Days
    38

    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
    DC-1 CARDIAC IMAGING MODULE
    K Number
    K811556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Diasonics, Inc.
    Date Received
    June 2, 1981
    Decision Date
    July 10, 1981
    Product Code
    DXK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXK Echocardiograph

    Similar 510(k) Clearances

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

    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IN-VISION IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9750 ATHENA ETHERNET OPTION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESSORY TO GENESIS III (GCFM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600

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

    Other Clearances by Diasonics, Inc.

    K Number Device Name
    K962662 VINGMED SOUND COLOR FLOW MAPPING SYSTEM
    K924079 CFM-800 COLOR FLOW MAPPING SYSTEM
    K911435 CPA/3.5 MHZ PROBE
    K905200 SACA, 3.5 MHZ PROBE
    K903562 CW DOPPLER 2.25 MHZ PROBE
    K903984 CW DOPPLER/4.5 MHZ
    K896637 ACCESS(TM), SOFTWARE RELEASE 4.11P
    K893518 MT/S SOFTWARE RELEASE 5.0.
    K894290 ACCESS TM
    K893881 ACCESS TM
    Search all 42 clearances from Diasonics, Inc. →