EFAI RTSuite CT HN-Segmentation System

Radiological Image Processing Software For Radiation Therapy

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 Rtsuite Ct Hn-segmentation System.

Pre-market Notification Details

Device IDK220264
510k NumberK220264
Device Name:EFAI RTSuite CT HN-Segmentation System
ClassificationRadiological Image Processing Software For Radiation Therapy
Applicant Ever Fortune.AI Co., Ltd. Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd., West Dist. Taichung City,  TW 403020
ContactJoseph Chang
CorrespondentTi-hao Wang
Ever Fortune.AI Co., Ltd. Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd., West Dist. Taichung City,  TW 403020
Product CodeQKB  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-31
Decision Date2022-04-28

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