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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 45 Results
ProductCode: KPS Applicant: GE MEDICAL SYSTEMS Decision Date To: 11/30/2021
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dynamiciq GE Medical Systems SCS K222895 11/22/2022
discovery mi gen2 GE Medical Systems, LLC. K211846 08/20/2021
pet vcar GE Medical Systems SCS K211247 07/27/2021
cardiq flow GE Medical Systems SCS K192277 02/14/2020
pet digital gating GE Medical Systems, LLC K180318 04/11/2018
discovery mi GE Medical Systems, L.L.C. K161574 08/11/2016
cortex id suite GE MEDICAL SYSTEMS, LLC K141074 09/18/2014
discovery iq GE MEDICAL SYSTEMS, LLC K141477 09/18/2014
discovery pet/ct 710 GE MEDICAL SYSTEMS, LLC K133657 03/21/2014
q. freeze (motion vue2) GE MEDICAL SYSTEMS, LLC K113408 02/24/2012