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510(k) Data Aggregation

    K Number
    K232302
    Device Name
    Pocket III
    Manufacturer
    Quantel Medical
    Date Cleared
    2024-04-26

    (269 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K993674
    Why did this record match?
    Device Name :

    Pocket III

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

    The Pocket III is intended to be used in ophthalmology clinical applications for measurement of corneal thickness by ultrasonic means with pachymetry. This device should be operated by doctors or other appropriately-trained healthcare professionals and should be used in health institutions. The device is not intended for fetal use.

    Device Description

    The Pocket III is a small hand-held device in pen-shaped design. Measurement results appear numerically on the LCD graphic display. The user can perform a basic cable transfer (USB-C) or activate Bluetooth to export data to a computer. The Pocket III is equipped with an integrated 30 MHz pachymetry probe. The ultrasonic transducer makes contact with, and transmits ultrasonic pulses through, the surface cornea. Echoes are returned from the anterior and posterior surfaces of the cornea.

    AI/ML Overview

    Acceptance Criteria and Device Performance Study for Quantel Medical Pocket III

    Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriterionReported Device Performance
    Accuracy+/- 5 microns
    Resolution1 micron
    Corneal thickness range150-1200 microns
    Ultrasonic Transducer Frequency30 MHz
    Tip Diameter1.2 mm
    Focal Point0.5 mm from tip
    Angle35 degrees
    Thermal Index
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