BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    SONON Ultrasound Imaging System, Model: SONON300C

    K Number: K211665 · Decision May 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    349

    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
    SONON Ultrasound Imaging System, Model: SONON300C
    K Number
    K211665
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healcerion Co., Ltd.
    Date Received
    June 1, 2021
    Decision Date
    May 16, 2022
    Product Code
    IYN
    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
    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 Healcerion Co., Ltd.

    K Number Device Name
    K212400 SONON Ultrasound Imaging System, Model: SONON 500L
    K170085 SONON Ultrasound Imaging System, Model: 300L
    K151339 SONON Ultrasound Imaging System (Model: SONON 300C)