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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 K211257
Device Name EFAI PACS Picture Archiving and Communication System
Applicant
Ever Fortune.AI Co., Ltd.
Rm. D, 8F., NO. 573, Sec. 2, Taiwan Blvd., West Dist.
Taichung City,  TW 403020
Applicant Contact Chen Ming-Fong
Correspondent
Ever Fortune.AI Co., Ltd.
Rm. D, 8F., NO. 573, Sec. 2, Taiwan Blvd., West Dist.
Taichung City,  TW 403020
Correspondent Contact Chen Ming-Fong
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/26/2021
Decision Date 09/10/2021
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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