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510(k) Data Aggregation

    K Number
    K190056
    Device Name
    KOWA VK-2s
    Manufacturer
    KOWA Co. Ltd. CHOFU
    Date Cleared
    2019-02-12

    (32 days)

    Product Code
    NFJ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA Co. Ltd. CHOFU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic ophthalmic cameras.
    Device Description
    The VK-2s consists of five types of software models including the: - VK-2s Standard . - . VK-2s VX-20 - VK-2s nonmyd ● - VK-2s nonmydWX - VK-2s Viewer . The VK-2s Standard, VK-2s VX-20, VK-2s nonmyd, and VK-2s nonmydWX are all software executed on a capture PC. The software acquires images from a retinal camera that the control software captures and puts on the capture PC. The software acquires images of the eye, stores images and processes images. The software displays acquired and processed images which are stored in a Server's database. The only difference between these four software programs are the devices that are supported for providing images: VK-2s Standard This software only supports images from: - KOWA VX series cameras, ● - KOWA nonmyd series cameras . - and supports file import. VK-2s VX-20 This software only supports images from: - . KOWA VX-20 series cameras, - and supports file import. ● VK-2s nonmyd This software only supports images from the KOWA nonmyd series cameras. VK-2s nonmydWX This software only supports images from the KOWA nonmydWX cameras. VK-2s Viewer This is a software executed on a viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in a server database. This software does not support image capture. The VK-2s software also takes advantage of three software packages included with the VK-2s. These are: VK-Montage Software This software allows the operator to create montages using multiple images VK-Scan VK Scan is software which can be used to import images located in a specified folder. VK-DDV The detailed database viewer provides advanced searching, viewing, image processing, printing, and reporting for your VK-2s database.
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    K Number
    K133755
    Device Name
    KOWA SL-17
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2014-03-11

    (92 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
    Device Description
    The KOWA SL-17 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and a stand.
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    K Number
    K112330
    Device Name
    KOWA VX-20
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2012-02-16

    (188 days)

    Product Code
    HKI, KOW, NFJ
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.
    Device Description
    The KOWA VX-20 is a retinal image shooting device which can take images with Mydriatic, Non-mydriatic, Fluorescein Angiography (FA), Red Free (RF), and Fundus AutoFluorescence angiography (FAF). The KOWA VX-20 is equipped with the filing function of captured images and the stored retinal images can display in the LCD monitor. The KOWA VX-20 is equipped with USB ports and an Ethernet port to be able to transfer images to the external device.
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    K Number
    K101628
    Device Name
    KOWA NONMYD WX
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2011-01-26

    (230 days)

    Product Code
    HKI, KOW
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retinal image can be stored to an image filing device through serial interface.
    Device Description
    The KOWA nonmyd WX is a retinal camera without mydriatic. Plane retinal image capturing function, that is normal image capturing, is equipped and furthermore, stereo image capturing function is done. The stereo images are able to take simultaneously in shingle shot, as these images are captured without image/parallax shifts. The KOWA nonmyd WX consists of a device body and external digital SLR camera, Single-Lens Reflex camera. The KOWA nonmed WX uses Xenon flash lamp as an image capturing light and Infrared LED lamp as an observation light. The KOWA nonmyd WX can be sued even in case which pupil has not been completely dilated in plane image capture mode, if it is more than 3.7mm in diameter. The KOWA nonmyd WX is equipped with a USB port to be able to transfer images to a computer. The KOWA nonmyd WX is designed to be able to link up to a filling system (KOWA portable VK-2), which can manage the digital images.
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    K Number
    K091039
    Device Name
    KOWA, FM-600, MODEL LSS50
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2009-08-07

    (116 days)

    Product Code
    MYC, CLA
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
    Device Description
    KOWA FM-600, here after refer to as FM-600, is a noninyasive flare photometry device that is able to assess anterior protein level quantitatively. FM-600 consists of three units, Measurement unit, Operating unit and Power supply unit. The measurement unit is contained optical system including Laser, photo receiver and CCD camera for observation. The operating unit is contained Observation monitor. Analyzer of detected photon intensity, printer for output and migratory mechanism of the units. The power supply unit is contained Power unit.
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    K Number
    K091098
    Device Name
    KOWAGENESIS-DF
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2009-08-07

    (113 days)

    Product Code
    HKI, CAM
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.
    Device Description
    KOWA GENESIS-Df is a hand-held mydriatic retinal camera which captures fundus image. It is equipped with a highly sensitive CCD camera, does not require film for photography, and allows for immediate viewing of the image after image is captured. It uses a lower flash light intensity than previous cameras requiring film, thereby providing greater user comfort. Compared to the predicate device, the KOWA GENESIS-Df uses less power during observation by using a visible LED light for observation lighting. Various weight savings were achieved with the KOWA GENESIS-Df camera to allow the user to be able to hold it in one hand with ease.
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    K Number
    K091683
    Device Name
    KOWA VX-10 A
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2009-07-02

    (22 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.
    Device Description
    The KOWA VX-10a is a simplified version of the predicate device [KOWA VX-10i (k062021)] by removing the indocyanine green (ICG) angiography mode, removing the use of Polaroid film as a recording media, and changing the availability of the data card for writing patient information as an optional accessory. In addition the lens coating was changed.
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    K Number
    K083387
    Device Name
    MODIFICATION TO KOWA NONMYD ALPHA-DIII
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2009-01-16

    (60 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA nonmyd ct-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retimal image can be stored to an image filing drive through serial ınterface
    Device Description
    KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic The retinal image can be stored to an image filing drive through serial ınterface
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    K Number
    K082767
    Device Name
    KOWA NONMYD ALPHA-DIII
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2008-10-21

    (29 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K080681
    Device Name
    KOWA GENESIS-D
    Manufacturer
    KOWA CO. LTD.
    Date Cleared
    2008-04-04

    (25 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOWA CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
    Device Description
    The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.
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