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510(k) Data Aggregation

    K Number
    K150415
    Device Name
    NilRead
    Manufacturer
    Perceptive Software
    Date Cleared
    2015-06-12

    (114 days)

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

    The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions.

    Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

    On mobile platforms, this device is not intended for diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the NilRead device, a picture archiving and communications system (PACS). It primarily describes the regulatory approval of the device and its indications for use, but it does not contain the detailed acceptance criteria for a study proving device performance, nor does it provide a study report.

    Therefore, I cannot extract the requested information from this document. The document confirms the device's classification and regulatory status but does not include the specifics of performance testing or clinical study results.

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