EFAI ChestSuite XR Pleural Effusion Assessment System

Radiological Computer-assisted Prioritization Software For Lesions

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 Chestsuite Xr Pleural Effusion Assessment System.

Pre-market Notification Details

Device IDK222076
510k NumberK222076
Device Name:EFAI ChestSuite XR Pleural Effusion Assessment System
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant Ever Fortune.AI Co., Ltd. RM. D, 8 F., NO. 573, SEC. 2, TAIWAN BLVD., WEST DIST. Taichung City,  TW 403020
ContactJoseph Chang
CorrespondentTi-Hao Wang
Ever Fortune.AI Co., Ltd. RM. D, 8 F., NO. 573, SEC. 2, TAIWAN BLVD., WEST DIST. Taichung City,  TW 403020
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-14
Decision Date2022-09-08

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