IMAGECHECKER-CT WORKSTATION

System, Image Processing, Radiological

R2 TECHNOLOGY, INC.

The following data is part of a premarket notification filed by R2 Technology, Inc. with the FDA for Imagechecker-ct Workstation.

Pre-market Notification Details

Device IDK023003
510k NumberK023003
Device Name:IMAGECHECKER-CT WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant R2 TECHNOLOGY, INC. 1195 W. FREMONT AVE. Sunnyvale,  CA  94087
ContactKathy O'shaughnessy
CorrespondentKathy O'shaughnessy
R2 TECHNOLOGY, INC. 1195 W. FREMONT AVE. Sunnyvale,  CA  94087
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-09
Decision Date2002-11-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260483290114 K023003 000
04260483290091 K023003 000

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