STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)

System, Image Processing, Radiological

STATRAD, LLC

The following data is part of a premarket notification filed by Statrad, Llc with the FDA for Stat Pacs Picture Archiving & Communication System (pacs).

Pre-market Notification Details

Device IDK092134
510k NumberK092134
Device Name:STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
ClassificationSystem, Image Processing, Radiological
Applicant STATRAD, LLC 4747 VIEWRIDGE AVE. SUITE 107 San Diego,  CA  92123
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-07-15
Decision Date2009-09-15
Summary:summary

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