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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 K222781
Device Name Augmento
Applicant
Deeptek Medical Imaging Private Limited
3rd floor, Ideas to impact, Pallod Farms 3, Baner
Pune,  IN 411045
Applicant Contact Kallol Sen
Correspondent
Liberty Management Group Ltd.
75 Executive Drive, Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/15/2022
Decision Date 04/11/2023
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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