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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K052157
Device Name INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
Applicant
Ge Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
Ge Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/08/2005
Decision Date 08/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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