IIVS INTEGRATED IMAGE VIEWING STATION

System, Digital Image Communications, Radiological

TERARECON, INC.

The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Iivs Integrated Image Viewing Station.

Pre-market Notification Details

Device IDK994329
510k NumberK994329
Device Name:IIVS INTEGRATED IMAGE VIEWING STATION
ClassificationSystem, Digital Image Communications, Radiological
Applicant TERARECON, INC. 200 GREGORY LN. SUITE C-100 Pleasent Hill,  CA  94523 -3389
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
TERARECON, INC. 200 GREGORY LN. SUITE C-100 Pleasent Hill,  CA  94523 -3389
Product CodeLMD  
CFR Regulation Number892.2020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-22
Decision Date2000-05-26
Summary:summary

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