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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K231001
Device Name DeepTek CXR Analyzer v1.0
Applicant
DeepTek Medical Imaging Pvt Ltd
3rd Floor, Ideas to Impact, Pallod Farms 3
Behind Vijay Sales, Baner
Pune,  IN 411405
Applicant Contact Carrillo Rory
Correspondent
DeepTek Medical Imaging Pvt Ltd
3rd Floor, Ideas to Impact, Pallod Farms 3
Behind Vijay Sales, Baner
Pune,  IN 411405
Correspondent Contact Carrillo Rory
Regulation Number892.2070
Classification Product Code
MYN  
Date Received04/07/2023
Decision Date 10/05/2023
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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