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510(k) Data Aggregation
K Number
K964803Device Name
UNIVISION ECHOCARDIOLOGY SYSTEM
Manufacturer
NETWORK CONCEPTS, INC.
Date Cleared
1997-02-11
(74 days)
Product Code
LMB
Regulation Number
892.2010Why did this record match?
Applicant Name (Manufacturer) :
NETWORK CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNIVISION™ Echocardiology System is a network system intended to use digital technology to acquire images from an echocardiogaphy ultrasound system for viewing outside the exam room and long term storage and retrieval on digital media.
Device Description
UNIVISION™ Echocardiology System is a real-time network system that provides review of echocardiograms either inside or outside the hospital environment. The exams are then archived on optical disc media. The UNIVISION™ Echocardiology System is comprised of three major subsystems: the Image Acquisition Unit (IAU); the Workstation; and the Archive Subsystem.
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