AQUARIUS WORKSTATION

System, Image Processing, Radiological

TERARECON, INC.

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

Pre-market Notification Details

Device IDK011142
510k NumberK011142
Device Name:AQUARIUS WORKSTATION
ClassificationSystem, Image Processing, 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 CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-13
Decision Date2001-05-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
INTUITION1 K011142 000
INTUITION8 K011142 000

Trademark Results [AQUARIUS WORKSTATION]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AQUARIUS WORKSTATION
AQUARIUS WORKSTATION
76322419 2600983 Live/Registered
TeraRecon, Inc.
2001-10-09

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