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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 20 of 88 Results
ProductCode: JAK Applicant: GE MEDICAL SYSTEMS Decision Date To: 06/29/2016
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deep learning image reconstruction for gemstone spectral imaging GE Medical Systems, LLC K201745 12/10/2020
faststroke, ct perfusion 4d GE Medical Systems SCS K193289 11/12/2020
hepatic vcar GE Medical Systems SCS K193281 03/20/2020
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
bone vcar (bvcar) GE Medical Systems SCS K183204 04/08/2019
thoracic vcar with gsi pulmonary perfusion GE Medical Systems SCS K183210 03/29/2019
snapshot freeze 2 GE Medical Systems, LLC. K183161 02/13/2019
gsi viewer with gsi fat option GE Medical Systems SCS K180225 04/24/2018
revolution ct GE Medical Systems, L.L.C. K163213 12/16/2016
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