FDA 510(k) Applications Submitted by Katelyn Rowley

FDA 510(k) Number Submission Date Device Name Applicant
K201745 06/26/2020 Deep Learning Image Reconstruction for Gemstone Spectral Imaging GE Medical Systems, LLC
K212067 07/02/2021 Deep Learning Image Reconstruction GE Healthcare Japan Corporation
K223514 11/22/2022 Spectral Bone Marrow GE Medical Systems, LLC
K213715 11/24/2021 Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition GE Medical Systems,LLC


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