EFAI PACS Picture Archiving And Communication System

System, Image Processing, Radiological

Ever Fortune.AI Co., Ltd.

The following data is part of a premarket notification filed by Ever Fortune.ai Co., Ltd. with the FDA for Efai Pacs Picture Archiving And Communication System.

Pre-market Notification Details

Device IDK211257
510k NumberK211257
Device Name:EFAI PACS Picture Archiving And Communication System
ClassificationSystem, Image Processing, Radiological
Applicant Ever Fortune.AI Co., Ltd. Rm. D, 8F., NO. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung City,  TW 403020
ContactChen Ming-fong
CorrespondentChen Ming-fong
Ever Fortune.AI Co., Ltd. Rm. D, 8F., NO. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung City,  TW 403020
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-09-10

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