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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 K013561
Device Name LIGHTSPEED 4.0 CT SCANNER SYSTEM
Applicant
GE Medical Systems
16800 Ryerson Rd.
New Berlin,  WI  53151
Applicant Contact LARRY A KROGER
Correspondent
Tuv Rheinland OF North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact REINER KRUMME
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/26/2001
Decision Date 11/08/2001
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
Recalls CDRH Recalls
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