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

    NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM

    K Number: K894568 · Decision Jan 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    69
    Applicant Total
    10
    Review Days
    172

    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
    NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
    K Number
    K894568
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5840
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Medical Systems, Inc.
    Date Received
    July 21, 1989
    Decision Date
    January 9, 1990
    Product Code
    KPQ
    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
    KPQ System, Simulation, Radiation Therapy

    Similar 510(k) Clearances

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

    ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONCENTRA SIMULATION 2.3

    FDA 510(k)
    FDA Class 2 ·Radiology

    IKOENGELO, VERSION 2

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTEGRATED BRACHYTHERAPY UNIT - DIGITAL

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

    Other Clearances by Advanced Medical Systems, Inc.

    K Number Device Name
    K955931 MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
    K952031 ULTRASOUND TRANSDUCER, MODEL US917
    K940898 MODEL IM77 INTRAPARTUM FETAL MONITOR
    K923335 ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION
    K932278 PFM PROFESSIONAL 7000 SPIROMETER
    K911657 FETAL SCALP SPIRAL ELECTRODE
    K902190 FETAL PULSE DETECTOR MODEL DOP-1
    K891672 PUL-TRON 100K PROFESSIONAL SPIROMETER
    K880756 MODEL PM-20A PHYSIOLOGICAL MONITOR