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

    INREACH PLANNING LAPTOP

    K Number: K082386 · Decision Sep 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    10
    Review Days
    28

    Basic Information

    Device Name
    INREACH PLANNING LAPTOP
    K Number
    K082386
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SUPERDIMENSION, LTD.
    Date Received
    August 19, 2008
    Decision Date
    September 16, 2008
    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 SUPERDIMENSION, LTD.

    K Number Device Name
    K102604 I-LOGIC INREACH SYSTEM
    K092365 INREACH SYSTEM, MODEL AAS00161-02
    K081379 MODIFICATION TO INREACH SYSTEM
    K080271 INREACH SYSTEM
    K071473 MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
    K062315 SUPERDIMENSION/BRONCHUS PREMIUM 2
    K052852 SUPERDIMENSION/BRONCHUS PREMIUM
    K052260 SUPERDIMENSION/BRONCHUS 4.1
    K042438 SUPERDIMENSION/BRONCHUS