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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
510(k) Number K213709
Device Name SIGNA PET/MR
Applicant
Ge Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Brian R Zielski
Correspondent
Ge Medical Systems, LLC
3200 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Brian R Zielski
Regulation Number892.1200
Classification Product Code
OUO  
Date Received11/24/2021
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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