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510(k) Data Aggregation

    K Number
    K103471
    Device Name
    UBM PLUS
    Manufacturer
    ACCUTOME, INC.
    Date Cleared
    2011-03-14

    (110 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K070943,K092837
    Why did this record match?
    Device Name :

    UBM PLUS

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

    The UBM Plus is designed for imaging the internal structure of the eye including opaque media and anterior segment pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye.

    Device Description

    The UBM Plus device is designed as a high frequency ultrasound B-Scan, which uses pulsed echo ultrasound to image the anterior segment of the eye. It utilizes a noncontact probe via a contact Scleral shell to generate and receive the ultrasound pulses, and provides a graphic display of returning pulse echoes to indicate the various structures.

    AI/ML Overview

    The UBM Plus device's performance data and acceptance criteria are outlined in the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Stated as "acceptable limits")Reported Device Performance
    Line
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    K Number
    K003141
    Device Name
    UBM PLUS, MODEL P45
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    2000-12-05

    (56 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UBM PLUS, MODEL P45

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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