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510(k) Data Aggregation

    K Number
    K991257
    Device Name
    FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
    Manufacturer
    FUJIFILM MEDICAL SYSTEM U.S.A., INC.
    Date Cleared
    1999-06-25

    (73 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K982146,K972380,K972256
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fuji wavelet compression is intended to be used in applications to compress digital medical image data.

    Device Description

    The subject device is a software product that consists of algorithms that perform irreversible wavelet compression on data found in digital medical images. This software may be used with current Fuji products (such as the Synapse™ Image & Information Management System, Fuji workstations) or future medical image communication or PACS devices. The subject device has three user-configurable modes of operation; 1) Base Line Mode, 2) Fast Decomp Mode-1 (high speed), and 3) Fast Decomp Mode-2 (high speed).

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for "Fuji wavelet compression" (also known as FFCOMP irreversible compression), a software product intended to compress digital medical image data. However, the document does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

    The document primarily focuses on:

    • Submitting entity and device identification.
    • Comparison to predicate devices (FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality display system for networks, PICTools Medical Compression Toolkit, Kodak Digital Science™ Medical Image and Information Library).
    • Description of the device - a software product performing irreversible wavelet compression with three user-configurable modes (Base Line, Fast Decomp Mode-1, Fast Decomp Mode-2).
    • Intended use (compress digital medical image data).
    • Technological characteristics and safety considerations (no patient contact, physician choice for compression, labeling of compressed images, human intervention).
    • A statement that "There are no performance standards applicable to the subject device have been issued under authority of section 514 of the Food. Drug, and Cosmetic Act."
    • A conclusion of substantial equivalence to predicate devices.
    • The FDA's clearance letter acknowledging substantial equivalence.

    Therefore, I cannot provide the requested table and study details as the information is not present in the provided text.

    The document specifically states: "For further details on the Fuji Wavelet compression Algorithm, see the product description in Annex 1, as well as the quantitative test results in Annex 2." These annexes are not provided in the input text, and would likely contain the information needed to answer your questions.

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