LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K984285
    Device Name
    OSTEOGRAM BONE DENSITOMETER
    Manufacturer
    COMPUMED, INC.
    Date Cleared
    1999-05-19

    (169 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsteoGram 2000 is indicated for use in estimating bone mineral density (BMD). The estimate of BMD and t-score may be used as an aid to the physician in determining fracture risk, and for monitoring changes in bone mass over time.
    Device Description
    The use of the currently marketed device involves exposures and processing of ordinary x-rays of the hand and scanning and analysis of those x-rays at a central processing lab. The present 510(k) is for a modification to the device, one that would allow the analysis of the x-rays at the same hospital or clinic where the x-rays were taken using off-the-shelf scanner and computer equipment. The proposed device is basically a change in software to provide user help and enhanced records keeping capability.
    Ask a Question
    K Number
    K955708
    Device Name
    COMPUMED DICON CLIENT
    Manufacturer
    COMPUMED, INC.
    Date Cleared
    1996-03-01

    (78 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPUMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This premarket notification covers the LAN and WAN teleradiology concept (transmission), and study information distribution functions. The CompuMed DICOM client is an on-site (LAN) or offsite (WAN or dial up) station for viewing patient information and images and reporting.
    Device Description
    The CompuMed DICOM client is a viewing station manufactured by CompuMed, Inc. The CompuMed DICOM client is an on-site (LAN) or offsite (WAN or dial up) station for viewing patient information and images and reporting. It supports industry standard information transmission and communication protocols.
    Ask a Question

    Page 1 of 1