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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
Recalls CDRH Recalls
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