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510(k) Data Aggregation
K Number
K051809Device Name
EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM
Manufacturer
Date Cleared
2005-08-15
(41 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INSIGHT A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medical Insight Easyl/iz™ PACS System is a Diagnostic Softcopy Reading software package to be used for primary diagnosis and clinical review of digital radiology images.
Device Description
The EasyViz(tm) system is designed as a diagnostic reading workstation system, which will be packaged with standard PC hardware and software, and is intended for use by radiologists and referring physicians.
EasyViz(tm) is capable of receiving and displaying DICOM images.
Images sent to EasyViz(tm) are converted into formats suitable for viewing in its framework, and are temporarily stored in a local cache (memory). The algorithms used to create JPEG and Wavelet compressed images are based on standard and accepted protocols.
Images sent to EasyViz(tm) can be viewed using an executable program on a standard PC, laptop, newspaper or other devices equipped with the appropriate hardware.
EasyViz(tm) uses standard "off-the-shelf" PC hardware and communicates using the standard 100 Mbit Ethernet TCP/IP stack. The network stack is superfluous to EasyViz(tm).
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