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510(k) Data Aggregation

    K Number
    K250883
    Device Name
    ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-09-18

    (178 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K063683,K231666
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ULTRASONIC PROBE UM-3R has been designed to be used with an Olympus endoscopic ultrasound center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs. This product is intended for use in adults.

    [Modes of operation]
    The Mode of Operation is B mode.

    [Operator qualifications]
    Appropriately trained healthcare professionals.

    [Device use settings]
    Professional healthcare facility (no domestic or special environments)

    The ULTRASONIC PROBE UM-G20-29R has been designed to be used with an Olympus endoscopic ultrasound center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs. This product is intended for use in adults.

    [Modes of operation]
    The Mode of Operation is B mode.

    [Operator qualifications]
    Appropriately trained healthcare professionals.

    [Device use settings]
    Professional healthcare facility (no domestic or special environments)

    Device Description

    The Ultrasonic Probes have been designed to be used with an Olympus Endoscopic Ultrasound Center, a Probe Driving Unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs.

    OLYMPUS Ultrasonic Probes UM-3R and UM-G20-29R are designed to be used in conjunction with gastrointestinal scopes, colonoscopes and duodenoscopes. The Probes are inserted into the patient through a channel of the endoscope.

    The Ultrasonic Probes consist of an insertion tube and a connector section. The connector section is connected to the Probe Driving Unit and the Probe Driving Unit is connected to the Ultrasound Center.

    The Ultrasonic Probe sends and receives electrical signals to and from the Ultrasound Center through the Probe Driving Unit. The Probes use a 20MHz frequency piezoelectric transducer and produce B-mode scan. They produce 360-degree mechanical/radial sonograms.

    The transducer is built into the insertion tube at the tip of the Probe. The transducer is rotated by the Probe Driving Unit within the insertion tube.

    The transducer converts the electrical signal to the ultrasound wave, sends it to the object, receives the reflected wave from the object and converts it to the electrical signal. The electrical signal is input to the Endoscopic Ultrasound Center and the ultrasound image is generated by the Endoscopic Ultrasound Center.

    UM-3R is used with the direct contact method and the sterile de-aerated water immersion method. UM-G20-29R is used with the direct contact method only.

    The Subject devices submitted for clearance each include one (1) major component: the Ultrasonic Probe, which is packaged with a Probe Holder (MH-245) and a Water-resistant Cap (MH-244).

    AI/ML Overview

    N/A

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