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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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