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510(k) Data Aggregation

    K Number
    K111346
    Device Name
    RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
    Manufacturer
    CALGARY SCIENTIFIC, INC.
    Date Cleared
    2011-09-09

    (119 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RESOLUTIONMD MOBILE MODEL RMB-MOB-2X

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

    The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.

    The ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.

    The ResolutionMD Mobile is not to be used for mammography.

    Device Description

    The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.

    AI/ML Overview

    The provided text describes ResolutionMD Mobile, a PACS software, but it does not contain the detailed information required to answer all the questions about specific acceptance criteria and study details. The text is primarily an FDA 510(k) clearance letter and an Indications for Use statement.

    Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
    6. If a standalone (algorithm only) performance study was done
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    The document states that the device is intended for "diagnostic, review, and analysis" and emphasizes that it "is not intended to replace full workstations and should be used only when there is no access to a workstation," and also "is not to be used for mammography." These are related to the intended use and limitations, but not specific performance metrics or acceptance criteria as would be found in a clinical study report.

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