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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 K020929
Device Name SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5
Applicant
GE Medical Systems
283 Rue De La Miniere Bp 34
Buc Cedex,  FR 78533
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact WOLFRAM GMELIN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/22/2002
Decision Date 04/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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