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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 K152034
Device Name FS-PACS
Applicant
Ec-Web Co., Ltd.
4f., #89, Taiyuan Rd., Datong Dist.
Taipei City,  TW 103
Applicant Contact KE-MIN JEN
Correspondent
Ec-Web Co., Ltd.
4f., #89, Taiyuan Rd., Datong Dist.
Taipei City,  TW 103
Correspondent Contact KE-MIN JEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/22/2015
Decision Date 02/23/2016
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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