BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip

    K Number: K222977 · Decision Feb 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    733
    Applicant Total
    5
    Review Days
    142

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    Basic Information

    Device Name
    DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
    K Number
    K222977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Macromedics BV
    Date Received
    September 28, 2022
    Decision Date
    February 17, 2023
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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    Other Clearances by Macromedics BV

    K Number Device Name
    K250429 DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
    K213439 FlexBoardTM, EagleBoardTM, BreastBoard SXTM
    K212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
    K142420 Patient Positioning Devices