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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lung computed tomography system, computer-aided detection
510(k) Number K042694
Device Name ADVANCED LUNG ANALYSIS II
Applicant
GE MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number892.2050
Classification Product Code
OEB  
Date Received09/30/2004
Decision Date 11/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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