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

    SMARTSPOT 2000

    K Number: K991578 · Decision Jun 3, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    11
    Review Days
    28

    Basic Information

    Device Name
    SMARTSPOT 2000
    K Number
    K991578
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CMT MEDICAL TECHNOLOGIES, LTD.
    Date Received
    May 6, 1999
    Decision Date
    June 3, 1999
    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 CMT MEDICAL TECHNOLOGIES, LTD.

    K Number Device Name
    K162224 ArtPix Mobile EZ2GO
    K110849 PRESTODR 4143
    K103038 DUET DRF
    K100400 PRESTODR PORTABLE
    K080890 SMARTSPOT PRIMAX
    K003438 SMART RAD
    K001111 PANORET, MODEL 1000A
    K961140 FLUOROPLUS CARDIAC TV
    K961307 SMART SPOT
    K953950 FLUORO CATHETER
    Search all 11 clearances from CMT MEDICAL TECHNOLOGIES, LTD. →