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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 24 Results
ProductCode: JAK Applicant: GE MEDICAL SYSTEMS, LLC Decision Date To: 12/06/2022
 
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deep learning image reconstruction GE Medical Systems, LLC. K213999 02/18/2022
discovery mi gen2 GE Medical Systems, LLC. K211846 08/20/2021
maxfov 2 GE Medical Systems, LLC. K203617 03/02/2021
deep learning image reconstruction for gemstone spectral imaging GE Medical Systems, LLC K201745 12/10/2020
revolution ct, revolution ct es, revolution apex, revolution ct with apex edition GE Medical Systems, LLC K191777 07/26/2019
deep learning image reconstruction GE Medical Systems, LLC. K183202 04/12/2019
snapshot freeze 2 GE Medical Systems, LLC. K183161 02/13/2019
low dose ct lung cancer screening option for qualified ge systems GE Medical Systems, LLC K151372 08/14/2015
revolution ct GE MEDICAL SYSTEMS, LLC K133705 04/11/2014
asir-v GE MEDICAL SYSTEMS, LLC K133640 03/25/2014
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