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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 19 Results
ProductCode: JAK Applicant: GE HEALTHCARE Decision Date To: 12/09/2022
 
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omni legend GE Healthcare K221932 09/02/2022
deep learning image reconstruction GE Healthcare Japan Corporation K220961 07/29/2022
revolution ascend GE Healthcare Japan Corporation K213938 02/04/2022
deep learning image reconstruction GE Healthcare Japan Corporation K212067 09/17/2021
starguide GE Healthcare K210173 03/29/2021
revolution ascend GE Healthcare Japan Corporation K203169 11/20/2020
deep learning image reconstruction GE Healthcare Japan Corporation K193170 12/13/2019
nm/ct 850, nm/ct 860 GE Healthcare K173816 04/17/2018
discovery nm/ct 670 czt GE HEALTHCARE K153402 01/21/2016
optima nm/ct 640 GE HEALTHCARE K121019 04/19/2012
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