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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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