AQUARIUSAPS SERVER

System, Image Processing, Radiological

TERARECON, INC.

The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Aquariusaps Server.

Pre-market Notification Details

Device IDK061214
510k NumberK061214
Device Name:AQUARIUSAPS SERVER
ClassificationSystem, Image Processing, Radiological
Applicant TERARECON, INC. 2955 CAMPUS DR., SUITE 325 San Mateo,  CA  94403
ContactEmilly Tojima
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-05-02
Decision Date2006-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
AQAPS1 K061214 000
AQAPS04 K061214 000

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