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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K143345
Device Name SIGNA Pioneer
Applicant
GE HEALTHCARE JAPAN CORPORATION
7-127, Asahigaoka 4-chome
HINO-SHI,  JP 191-8503
Applicant Contact Toru Shimizu
Correspondent
GE HEALTHCARE JAPAN CORPORATION
7-127, Asahigaoka 4-chome
HINO-SHI,  JP 191-8503
Correspondent Contact Toru Shimizu
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received11/21/2014
Decision Date 07/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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