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

    PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS

    K Number: K110482 · Decision Mar 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    17
    Review Days
    28

    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
    PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
    K Number
    K110482
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Teratech Corp.
    Date Received
    February 18, 2011
    Decision Date
    March 18, 2011
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

    Similar 510(k) Clearances

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

    ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ES-Series

    FDA 510(k)
    FDA Class 2 ·Radiology

    EPIQ Series Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOGIQ e

    FDA 510(k)
    FDA Class 2 ·Radiology

    SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6

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

    Other Clearances by Teratech Corp.

    K Number Device Name
    K150533 Terason uSmart3200T Ultrasound System
    K150148 Terason uSmart3300 Ultrasound System
    K140773 TERASON USMART3300 ULTRASOUND SYSTEM
    K140834 TERASON USMART3400 ULTRASOUND SYSTEM
    K140524 TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
    K131209 TERASON USMART3200T ULTRASOUND SYSTEM
    K112953 TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
    K110020 TERASON T3200 ULTRASOUND SYSTEM
    K080234 TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
    K051334 TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER
    Search all 17 clearances from Teratech Corp. →