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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K172768
Device Name ZOOM
Applicant
Zetta Medical Technologies, LLC
1313 Ensell Rd.
Lake Zurich,  IL  60047
Applicant Contact Main M. Ghazal
Correspondent
Zetta Medical Technologies, LLC
1313 Ensell Rd.
Lake Zurich,  IL  60047
Correspondent Contact Main M. Ghazal
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/13/2017
Decision Date 04/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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