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

    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

    K Number: K250429 · Decision Mar 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    124
    Same Product Code
    717
    Applicant Total
    4
    Review Days
    33

    Basic Information

    Device Name
    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
    K Number
    K250429
    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
    February 14, 2025
    Decision Date
    March 19, 2025
    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

    Similar 510(k) Clearances

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

    Cranial 4Pi Immobilization

    FDA 510(k)
    FDA Class 2 ·Radiology

    MapRT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mobius3D (4.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Klarity SGRT System (ARSG-E1A, ARSG-E3A)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Identify (4.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface

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

    Other Clearances by MacroMedics BV

    K Number Device Name
    K222977 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
    K213439 FlexBoardTM, EagleBoardTM, BreastBoard SXTM
    K212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips