BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    D2P

    K Number: K183489 · Decision Aug 29, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    9
    Review Days
    255

    Basic Information

    Device Name
    D2P
    K Number
    K183489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3D Systems, Inc.
    Date Received
    December 17, 2018
    Decision Date
    August 29, 2019
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

    Similar 510(k) Clearances

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

    CustomSurg OrthoPlanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    uOmniscan

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mosaic (V1.0.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    UroNav 4

    FDA 510(k)
    FDA Class 2 ·Radiology

    TechLive

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMARTDent

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

    Other Clearances by 3D Systems, Inc.

    K Number Device Name
    K243173 Salto Talaris Ankle PSI System
    K243174 Cadence Ankle PSI System
    K241148 Salto Talaris Ankle PSI System
    K241326 Cadence Ankle PSI System
    K231834 VSP PEEK Cranial Implant
    K231585 Vantage PSI System
    K190044 VSP Orthopedics System
    K151285 VSP Cranial System