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510(k) Data Aggregation

    K Number
    K971760
    Device Name
    COLORPOINT OR PROFESSIONAL COLORPOINT
    Manufacturer
    SEIKO INSTRUMENTS USA, INC.
    Date Cleared
    1997-10-01

    (142 days)

    Product Code
    LMC
    Regulation Number
    892.2040
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COLORPOINT OR PROFESSIONAL COLORPOINT

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

    The device is indicated for producing full-bleed thermal wax prints in various sizes from medical image signal inputs.

    Device Description

    Color point 820 PS, 830 Ps and Professional Colorpoint 2 Model 04.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Seiko Instruments, Inc. ColorPoint 820PS and 830PS Color Printer. This document specifically states the device is an "Unclassified Procode: 90 LMC" and is intended for "producing full-bleed thermal wax medical image signal inputs."

    Based on the content of these documents, it is not possible to provide the requested information about acceptance criteria and a study proving the device meets those criteria. This type of FDA clearance letter does not typically contain detailed performance specifications, clinical study results, or information regarding ground truth and expert reviews for medical devices.

    The FDA 510(k) clearance process for unclassified devices like this color printer often relies on substantial equivalence to a predicate device rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics.

    Therefore, I cannot populate the table or answer the specific questions about the study from the given text.

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