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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 K201560
Device Name Auto Lung Nodule Detection
Applicant
Samsung Electronics Co.,Ltd.
129, Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Applicant Contact Jaesang Noh
Correspondent
Samsung Electronics Co.,Ltd.
129, Samsung-Ro, Yeongtong-Gu
Suwon-Si,  KR 16677
Correspondent Contact Jaesang Noh
Regulation Number892.2070
Classification Product Code
MYN  
Date Received06/10/2020
Decision Date 08/31/2021
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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