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

    dS Sentinelle Breast 16ch 1.5T Coil

    K Number: K213735 · Decision Aug 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    6
    Review Days
    252

    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
    dS Sentinelle Breast 16ch 1.5T Coil
    K Number
    K213735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Invivo Corporation (Business Trade Name: Philips)
    Date Received
    November 29, 2021
    Decision Date
    August 8, 2022
    Product Code
    MOS
    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
    MOS Coil, Magnetic Resonance, Specialty

    Similar 510(k) Clearances

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

    0.55T 12Ch Breast Coil

    FDA 510(k)
    FDA Class 2 ·Radiology

    HD 8Ch Wrist Array

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only

    FDA 510(k)
    FDA Class 2 ·Radiology

    Smart Fit TorsoCardiac 1.5T

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only

    FDA 510(k)
    FDA Class 2 ·Radiology

    3.0T AIR 32CH HNA

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

    Other Clearances by Invivo Corporation (Business Trade Name: Philips)

    K Number Device Name
    K232762 dS Breast Coil 7ch 1.5T
    K222325 8ch Wrist Coil
    K222257 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
    K213727 dS Sentinelle Breast 16ch 3.0T Coil
    K213351 ds Head 32ch 3.0T