BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)

    K Number: K925929 · Decision Mar 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    141
    Applicant Total
    2
    Review Days
    112

    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
    RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)
    K Number
    K925929
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2020
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rstar, Inc.
    Date Received
    November 23, 1992
    Decision Date
    March 15, 1993
    Product Code
    LMD
    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
    LMD System, Digital Image Communications, Radiological

    Similar 510(k) Clearances

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

    IIVS INTEGRATED IMAGE VIEWING STATION

    FDA 510(k)
    FDA Class 1 ·Radiology

    STENTOR, PAGEVIEW

    FDA 510(k)
    FDA Class 1 ·Radiology

    RAYPAX WEB CLINICAL SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0

    FDA 510(k)
    FDA Class 1 ·Radiology

    SAMSUNG RAYPAX SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all

    Other Clearances by Rstar, Inc.

    K Number Device Name
    K925994 RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)