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510(k) Data Aggregation

    K Number
    K983516
    Device Name
    TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-12-23

    (77 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K963983
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). Tomographic Imaging (SPECT) for non Positron Emitter.

    Device Description

    The Transmission Kit, Trans-CT for E.CAM, Model NSTR-050A is a software option for the ECAM gamma camera system that will be used to process and reconstruct acquired transmission and emission data. This software will be installed into the GMS-5500A/UI image processor which is part of the ECAM system. When the external flood source of this system is combined with a parallel-hole collimator, this system can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images.

    AI/ML Overview

    The provided text, K983516, is a 510(k) Summary for a medical device called "Transmission Kit, Trans-CT, Model NSTR-050A." This document describes the device, its intended use, and its technological characteristics, and importantly, declares substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    The summary instead focuses on demonstrating that the device is substantially equivalent to a previously cleared device (Siemens E.CAM Profile Attenuation Correction, K963983) based on its intended use and technological characteristics. This type of submission generally relies on demonstrating similarity to a predicate, rather than presenting a novel clinical study with explicit acceptance criteria and performance data for the new device.

    Therefore, I cannot provide the requested information from the given text. The K983516 document does not include:

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