LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K183525
    Device Name
    EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2019-09-06

    (261 days)

    Product Code
    PSV, ITX, IYN
    Regulation Number
    892.1550
    Why did this record match?
    Product Code :

    PSV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, EndoTherapy accessories such as an aspiration biopsy needle. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.
    Device Description
    The BF-UC190F has been designed to be used with the video system center, light source, documentation equipment, display monitor, and Endo Therapy accessories such as an aspiration biopsy needle. The BF-UC190F is intended for endoscopic real-time ultrasound imaging for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus. The BF-UC190F is a flexible video endoscope and a modification of the XBF-UC180F-DT8 which was previously cleared under K070983. The BF-UC190F consists of three parts: the control section, the insertion section, and the connector section.
    Ask a Question
    K Number
    K070983
    Device Name
    OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Date Cleared
    2007-07-05

    (90 days)

    Product Code
    PSV, ITX, IYN
    Regulation Number
    892.1550
    Why did this record match?
    Product Code :

    PSV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Trans-esoph. (non-Card.), Airways and tracheobronchial tree.
    Device Description
    OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE has been designed to be used with the SSD-Alpha5 (K041916) and SSD-Alpha10(K043196) diagnostic ultrasound systems (ALOKA CO.,LTD.), video system center, light source, documentation equipment, display monitor, and endo-therapy accessories such as aspiration blopsy needle. The subject device is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airway, tracheobronchial tree, esophagus, and surrounding organs.
    Ask a Question
    K Number
    K021204
    Device Name
    OLYMPUS BF TYPE UM40
    Manufacturer
    OLYMPUS OPTICAL CO., LTD.
    Date Cleared
    2002-05-01

    (15 days)

    Product Code
    PSV, ITX, ODG
    Regulation Number
    892.1550
    Why did this record match?
    Product Code :

    PSV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intraluminal ultrasound for upper airways and tracheobronchial tree
    Device Description
    This subject device has been designed to be used with an OLYMPUS endoscopic ultrasound center, light source, documentation equipment, display monitor, endotherapy accessories and other ancillary equipment for endoscopic ultrasonic imaging of the upper airways and trancheobronchial tree.
    Ask a Question

    Page 1 of 1