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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K981352
Device Name VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
ADVANCED TECHNOLOGY CENTER
HAIFA,  IL 31004
Applicant Contact YAIR FRIEDMAN
Correspondent
GE MEDICAL SYSTEMS F.I. HAIFA
ADVANCED TECHNOLOGY CENTER
HAIFA,  IL 31004
Correspondent Contact YAIR FRIEDMAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received04/14/1998
Decision Date 07/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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