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    K Number
    K081829
    Device Name
    CAPIMAGE
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT A/S
    Date Cleared
    2008-07-11

    (14 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K011611
    Why did this record match?
    Device Name :

    CAPIMAGE

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

    The CapIMAGE Gamma Camera System is intended to produce planar images depicting the anatomical distributions of single photon emitting radioisotopes in the human body within the energy range of 59kev to 167kev. The system provides software applications for processing, analyzing, and displaying medical images for interpretation by medical personnel.

    The CapIMAGE Gamma Camera System is intended for examination (and diagnosis) of disorders and diseases in the thyroid gland, the heart and other small organs. The device is not interpretative. Data from the device are interpreted by medical personnel who, based on these, make the clinical diagnosis.

    Device Description

    The CapIMAGE is a mobile Small Field of View (SFOV) gamma camera system utilizing a scintillation detector to detect gamma rays. The CapIMAGE is designed to be manually transported and deployed for scanning of patients in laying, sitting or standing positions. The system can operate powered from mains or from the internal battery source for at least 60 min.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information for the CapIMAGE Gamma Camera System, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the CapIMAGE device are based on compliance with industry standards, specifically NEMA NU 1-2001 for performance specifications. The reported device performance metrics are presented as meeting or being within the specified limits of these standards. The document doesn't provide specific quantitative acceptance thresholds for each performance characteristic but implies compliance.

    Performance CharacteristicAcceptance Criteria (Implied by Standards Compliance)Reported Device Performance
    Energy rangeNEMA NU 1-2001 compliant59kev – 167kev
    Detector UFOVNEMA NU 1-2001 compliantØ 210 mm (8.3")
    Intrinsic Spatial Res.NEMA NU 1-2001 compliant≤ ± 3.7mm @ UFOV / FWHM
    Energy ResolutionNEMA NU 1-2001 compliant≤ 9.4% @ Tc-99m
    Spatial LinearityNEMA NU 1-2001 compliant≤ ± 0.5mm @ UFOV
    Flood Field UniformityNEMA NU 1-2001 compliant≤ ± 2.7% @ UFOV Intrinsic
    Intrinsic Uniformity, UFOV, DifferentialNEMA NU 1-2001 compliant180k cps @ 20% loss
    Spatial Resolution, FWHM, LEGP Tc-99m.NEMA NU 1-2001 compliant
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