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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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