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510(k) Data Aggregation
K Number
K082808Device Name
IMAGESVR PACS
Manufacturer
Date Cleared
2009-01-09
(107 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JAGUAR TECHNOLOGY LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ImageSVR PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
To support the diagnostic interpretation of mammography studies, ImageSVR PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
Device Description
The ImageSVR PACS is a suite of applications designed and produced by Jaguar Technology Ltd. It is a client-server based software system manages archiving, retrieving and displaying medical images. The server side application is ImageSVR PACS SERVER. And client side is ImageSVR PACS CLIENT.
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