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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
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