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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 K183202
Device Name Deep Learning Image Reconstruction
Applicant
GE Medical Systems, LLC.
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Lee Bush
Correspondent
GE Medical Systems, LLC.
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Lee Bush
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/19/2018
Decision Date 04/12/2019
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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