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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K201745
Device Name Deep Learning Image Reconstruction for Gemstone Spectral Imaging
Applicant
GE Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Katelyn Rowley
Correspondent
GE Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Katelyn Rowley
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/26/2020
Decision Date 12/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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