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

    IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR

    K Number: K082364 · Decision Sep 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    32
    Same Product Code
    51
    Applicant Total
    9
    Review Days
    43

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
    K Number
    K082364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topcon Corp.
    Date Received
    August 18, 2008
    Decision Date
    September 30, 2008
    Product Code
    NFJ
    Advisory Committee
    Radiology
    Review Advisory Committee
    OP
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NFJ System, Image Management, Ophthalmic

    Similar 510(k) Clearances

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

    Harmony Referral System with Harmony OCT Viewer (Octave)

    FDA 510(k)
    FDA Class 2 ·Radiology

    iCare ALTIUS CW

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMAGEnet6 Ophthalmic Data System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CALLISTO eye

    FDA 510(k)
    FDA Class 2 ·Radiology

    Harmony

    FDA 510(k)
    FDA Class 2 ·Radiology

    CALLISTO eye

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

    Other Clearances by Topcon Corp.

    K Number Device Name
    K141325 TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
    K133667 SLIT LAMP SL-D701
    K130289 TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
    K100207 NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
    K092470 OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
    K090115 RETINA CAMERA TRC-NW7SF MARK II
    K063388 TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
    K041367 TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA