UNIPACS WORKSTATION

System, Image Processing, Radiological

UNIVERSAL PACS, INC.

The following data is part of a premarket notification filed by Universal Pacs, Inc. with the FDA for Unipacs Workstation.

Pre-market Notification Details

Device IDK023476
510k NumberK023476
Device Name:UNIPACS WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant UNIVERSAL PACS, INC. 127 ALBERT HART DR. Baton Rouge,  LA  70803
ContactJohn M Tyler
CorrespondentJohn M Tyler
UNIVERSAL PACS, INC. 127 ALBERT HART DR. Baton Rouge,  LA  70803
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-16
Decision Date2003-01-07
Summary:summary

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