CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY

System, Image Processing, Radiological

GE HEALTHCARE INTEGRATED IT SOLUTIONS

The following data is part of a premarket notification filed by Ge Healthcare Integrated It Solutions with the FDA for Centricity Radiology Ra600, Cardiology Ca1000 And Digital Hardcopy.

Pre-market Notification Details

Device IDK063628
510k NumberK063628
Device Name:CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
ClassificationSystem, Image Processing, Radiological
Applicant GE HEALTHCARE INTEGRATED IT SOLUTIONS 540 W. NW HIGHWAY Barrington,  IL  60010
ContactKaren M Lunde
CorrespondentSilvia Ankova
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-12-06
Decision Date2006-12-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682125260 K063628 000

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