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510(k) Data Aggregation
K Number
K031638Device Name
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
Manufacturer
Date Cleared
2003-07-21
(55 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ELECTROMED IMAGING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CVIEW™ is a high performance, digital, cardiac image viewer. The System supports DICOM 3.x and higher cardiac and angio images and displays them in their original dynamic mode. The CVIEW accepts images from DICOM 3.x CDs or can be configured to read DICOM 3 images from a DICOM Archive Server. The CVIEW allows immediate playback of images from any patient stored on the system and burning CDs in the DICOM part 10 - file format.
It represents the next generation in network cardiac review systems. Features include 1024 viewing, security, report generation, multi-modality viewing, databasing as well as instant access to hundreds of cases on-line or thousands through the network.
Device Description
Cardio Vascular Information Enhanced Workstation™ (CVIEW)™ is a viewing stations for Cath, Echo and Angio case studies, represent the next generation in network cardiac review systems. Features include 1024 viewing, security, report generation, multi-modality viewing, databasing as well as instant access to hundreds of cases on-line or thousands through the network.
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