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510(k) Data Aggregation

    K Number
    K030634
    Device Name
    ENDOS DC
    Manufacturer
    VILLA SISTEMI MEDICALI S.P.A.
    Date Cleared
    2003-07-21

    (144 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K992610
    Why did this record match?
    Device Name :

    ENDOS DC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

    Device Description

    extra oral source X-ray system for dental radiographic examination of the teeth

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called ENDOS DC, which is an extraoral source X-ray system for dental radiographic examination. It compares the ENDOS DC to a predicate device, the GENDEX DENTSPLY model 765DC.

    Based on the information provided, here's an analysis of the acceptance criteria and the study:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state "acceptance criteria" in a typical quantitative performance metric sense (e.g., sensitivity, specificity, accuracy) for a medical imaging device's diagnostic capability. Instead, it focuses on technical specifications and safety features to demonstrate substantial equivalence to a predicate device.

    The premise of this 510(k) is that if ENDOS DC meets or performs comparably to the predicate device in these technical areas, it is considered safe and effective for its intended use. Therefore, the "acceptance criteria" are implied to be the specifications of the predicate device.

    Acceptance Criteria (Predicate Device K992610: GENDEX 765 DC)Reported Device Performance (ENDOS DC)
    Intended use: extra oral source X-ray system for dental radiographic examinationIntended use: extra oral source X-ray
    system for dental
    radiographic examination
    of the teeth
    High Voltage value: 65 kVp +/- 3kVHigh Voltage value: 65 kVp+/-5%
    Tube current: 7 mA +/- 5%Tube current: 4-5 mA +/-5%
    Focal spot size: 0.4 mm (IEC 336)Focal spot size: 0.7 mm (IEC 336)
    Anode inclination: 12.5°Anode inclination: 19°
    Total filtration: 2.0 mm AlTotal filtration: > 2.0 mm Al
    HVL: 2.0 mm AlHVL: > 1.5 mm Al
    H.V. generator: High frequencyH.V. generator: High frequency
    X-Ray exposure time control: Automatic - pre-programmed Microprocessor ControlledX-Ray exposure time control: Automatic - pre-
    programmed
    Microprocessor
    Controlled
    X-Ray exposure timing: 0.020 sec to 2 secX-Ray exposure timing: 0.010 sec to 2 sec
    Electrical characteristics: 120 V, 5 impulsive A maxElectrical characteristics: 120 V,
    4.5 impulsive A max
    Focus film distance: > 20 cm or > 30cmFocus film distance: > 20 cm
    or > 30cm
    Leakage radiation:
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