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510(k) Data Aggregation

    K Number
    K022001
    Device Name
    MPOWER, MODEL 712 SERIES
    Manufacturer
    POSITRON CORP.
    Date Cleared
    2002-07-12

    (23 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    POSITRON CORP.

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

    The Positron Corporation POSICAM HZ™, POSICAM HZL™, mPower™ PET scanners are intended to be used for whole body, multislice, positron emission tomography diagnostic imaging.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA to Positron Corporation for their POSICAM HZ™, POSICAM HZL™, and mPower™ PET scanners.

    This document does not contain information regarding specific acceptance criteria, reported device performance metrics, sample sizes for test sets, data provenance, details about expert involvement in ground truth establishment, adjudication methods, multi-reader multi-case study results, standalone algorithm performance, or training set details.

    Therefore, I cannot provide the requested table and information based solely on the input text. The letter only confirms that the device has been found substantially equivalent to a predicate device and can be marketed. It does not elaborate on the specific studies or data used to support this determination.

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