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    K Number
    K151007
    Device Name
    21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
    Manufacturer
    JVC KENWOOD CORPORATION
    Date Cleared
    2015-05-08

    (23 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K131137
    Why did this record match?
    Device Name :

    21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)

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

    21.3 inch (54 cm) inch Color Digital Mammography 5M pixel LCD Monitor CCL550i2 (CL21550) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

    Device Description

    CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.

    AI/ML Overview

    The provided text describes the JVC KENWOOD Corporation's 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2 (CL21550) and its substantial equivalence to a predicate device. This document is a 510(k) premarket notification to the FDA. It does not describe a study involving human readers or AI, but rather the technical specifications and testing of a medical display monitor.

    Therefore, many of the requested items related to clinical studies, human experts, and AI effectiveness are not applicable to the provided document. The information available focuses on engineering specifications and direct performance measurements of the display device.

    Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" or "Not Provided" where the information cannot be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (SPEC)Reported Device Performance
    Declared array size (spec): 422.4(H)mm x 337.92(V) mmActual array size (measured): 422.7(H)mm x 338.0(V)mm
    Luminance Max (Lmax)=1000cd/m², Luminance Min (typ) = 0.77cd/m² at Lmax=1000cd/m²Min.700cd/m² Typ. 1000cd/m² (as LCD component), 500cd/m² calibrated luminance. Minimum luminance at Lmax=1000cd/m² is not explicitly re-stated, but the calibrated luminance is 500 cd/m².
    Luminance Max recommend: Lmax(r)=500cd/m², Lmin(r)=0.8cd/m²Calibrated luminance is 500 cd/m².
    Intrinsic bit-depth of the panel: 10 bit per each pixel10.0 bit grayscale (1024 steps) achieved by 16bit LUT (Look-up Table)
    Intrinsic luminance response: dJND per dP30%"Refer to actual Luminance uniformity data." (Specific numerical performance not provided in summary)
    Luminance uniformity: Less than 30% based on AAPM-TG18 4.4"Refer to actual Luminance uniformity data." (Specific numerical performance not provided in summary)
    Geometrical distortion: Less than 2.0% based on AAPM-TG18"Refer to actual Geometrical Distortion data." (Specific numerical performance not provided in summary)
    Bi-directional reflection distribution function: Refer to Max allowable ambient luminance in Tables 4 and 5 on AAPM-TG18 4.2.4."Refer to actual Reflectance Data." (Specific numerical performance not provided in summary)
    Pixel fill factor: 30% Min."Refer to Data of Pixel fill factor." (Specific numerical performance not provided in summary)
    Noise power spectrum (weiner spectrum)"Refer to actual data." (Specific numerical performance not provided in summary)
    Veiling glare: Glare Ratio (GR) ≥ 400 GR=(Lb-Ln)/(L-Ln) based on AAPM-TG18 4.7.4"Refer to actual veiling glare ratio data." (Specific numerical performance not provided in summary)
    Chromaticity: Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4"Refer to Chromaticity actual data." (Specific numerical performance not provided in summary)
    Artifacts: pixel dropouts including spatial distribution: Class (pixel) II. Refer to table 3 on 3.4.13 ISO13406-2."Refer to table 3 on 3.4.13 ISO13406-2." (Specific performance details not provided in summary)
    Artifacts: phase/clock issues flicker, ringing, ghosting, image sticking"By visible check, no ringing, ghosting image sticking." (Flicker, phase/clock issues not explicitly addressed as "no.")
    Spatial resolution, spatial MTF"Refer to actual MTF data." (Specific numerical performance not provided in summary)
    Temporal response: Rise Time Tr, Fall Time Tf, Tr, Tf
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