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

    ELK LASER IMAGER, MODEL EL-DRY 4000

    K Number: K011949 · Decision Aug 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    120
    Applicant Total
    2
    Review Days
    69

    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
    ELK LASER IMAGER, MODEL EL-DRY 4000
    K Number
    K011949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2040
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nishimoto Sangyo Co., Ltd.
    Date Received
    June 21, 2001
    Decision Date
    August 29, 2001
    Product Code
    LMC
    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
    LMC Camera, Multi Format, Radiological

    Similar 510(k) Clearances

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

    SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRYVIEW CHROMA IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CYPHER DICOM PRINT SOLUTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARESTREAM DRYVIEW 5850 LASER IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    SONY UP-DF750 DIGITAL FILM IMAGER

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

    Other Clearances by Nishimoto Sangyo Co., Ltd.

    K Number Device Name
    K984409 ELK LASER FILM DIGITIZER