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Found 17 results
510(k) Data Aggregation
K Number
K190056Device Name
KOWA VK-2s
Manufacturer
KOWA Co. Ltd. CHOFU
Date Cleared
2019-02-12
(32 days)
Product Code
NFJ
Regulation Number
892.2050Why 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
K133755Device Name
KOWA SL-17
Manufacturer
KOWA CO. LTD.
Date Cleared
2014-03-11
(92 days)
Product Code
HJO
Regulation Number
886.1850Why 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
K112330Device Name
KOWA VX-20
Manufacturer
KOWA CO. LTD.
Date Cleared
2012-02-16
(188 days)
Product Code
HKI, KOW, NFJ
Regulation Number
886.1120Why 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
K101628Device Name
KOWA NONMYD WX
Manufacturer
KOWA CO. LTD.
Date Cleared
2011-01-26
(230 days)
Product Code
HKI, KOW
Regulation Number
886.1120Why 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
K091039Device Name
KOWA, FM-600, MODEL LSS50
Manufacturer
KOWA CO. LTD.
Date Cleared
2009-08-07
(116 days)
Product Code
MYC, CLA
Regulation Number
886.1570Why 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
K091098Device Name
KOWAGENESIS-DF
Manufacturer
KOWA CO. LTD.
Date Cleared
2009-08-07
(113 days)
Product Code
HKI, CAM
Regulation Number
886.1120Why 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
K091683Device Name
KOWA VX-10 A
Manufacturer
KOWA CO. LTD.
Date Cleared
2009-07-02
(22 days)
Product Code
HKI
Regulation Number
886.1120Why 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
K083387Device Name
MODIFICATION TO KOWA NONMYD ALPHA-DIII
Manufacturer
KOWA CO. LTD.
Date Cleared
2009-01-16
(60 days)
Product Code
HKI
Regulation Number
886.1120Why 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
K082767Device Name
KOWA NONMYD ALPHA-DIII
Manufacturer
KOWA CO. LTD.
Date Cleared
2008-10-21
(29 days)
Product Code
HKI
Regulation Number
886.1120Why 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
K080681Device Name
KOWA GENESIS-D
Manufacturer
KOWA CO. LTD.
Date Cleared
2008-04-04
(25 days)
Product Code
HKI
Regulation Number
886.1120Why 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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