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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 K213668
Device Name SIGNA Hero
Applicant
GE Healthcare (GE Medical Systems, LLC)
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Sandra Westphal
Correspondent
GE Healthcare (GE Medical Systems, LLC)
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Sandra Westphal
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received11/22/2021
Decision Date 01/20/2022
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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