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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 K183161
Device Name SnapShot Freeze 2
Applicant
GE Medical Systems, LLC.
3000 N. Grandview Blvd
waukesha,  WI  53188
Applicant Contact laura turner
Correspondent
GE Medical Systems, LLC.
3000 N. Grandview Blvd
waukesha,  WI  53188
Correspondent Contact laura turner
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received11/15/2018
Decision Date 02/13/2019
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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