BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    VIEW NT

    K Number: K000474 · Decision Apr 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    23
    Review Days
    65

    Basic Information

    Device Name
    VIEW NT
    K Number
    K000474
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ELECTROMED INTL., LTD.
    Date Received
    February 14, 2000
    Decision Date
    April 19, 2000
    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 ELECTROMED INTL., LTD.

    K Number Device Name
    K003688 VIEW READING STATION
    K990759 VIEW COM
    K974255 CD-R STATION AND VRS-2000
    K971176 VIEW ARCHIVING STATION
    K950694 COMPACT-X
    K880050 EDEC 60R
    K875341 EDEC 60 R/F
    K875342 EDEC 90C
    K871145 EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR
    K870851 EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR
    Search all 23 clearances from ELECTROMED INTL., LTD. →