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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
Recalls CDRH Recalls
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