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

    SNT IMAGE ANALYSIS SYSTEM

    K Number: K992354 · Decision Oct 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    27
    Review Days
    90

    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
    SNT IMAGE ANALYSIS SYSTEM
    K Number
    K992354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Navigation Technologies, Inc.
    Date Received
    July 14, 1999
    Decision Date
    October 12, 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.

    2D Hip Planning Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    CustoMED Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    Helion Viewer Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    CMN Capillary Function with Virtual Expert for MRI, CT and CBCT

    FDA 510(k)
    FDA Class 2 ·Radiology

    SubtleHD-PET (1.x)

    FDA 510(k)
    FDA Class 2 ·Radiology

    HipGuide (V 1.0.0.0)

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

    Other Clearances by Surgical Navigation Technologies, Inc.

    K Number Device Name
    K000246 RADIOCAMERAS EXTRACRANIAL SYSTEM
    K994355 RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
    K992461 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
    K992927 STEALTHSTATION TREATMENT GUIDANCE PLATFORM
    K993021 METRX SYSTEM
    K991468 IMMERGE IMAGE CORRELATION
    K990214 FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
    K983670 STEALTHSTATION SYSTEM
    K984000 STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
    K983397 STEALTHSTATION TREATMENT GUIDANCE PLAFFORM
    Search all 27 clearances from Surgical Navigation Technologies, Inc. →