Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine

System, X-ray, Mobile

Yian Medical Technology (Haining) Co., Ltd

The following data is part of a premarket notification filed by Yian Medical Technology (haining) Co., Ltd with the FDA for Heart5r-110 Portable X-ray Machine, Heart3r-110 Portable X-ray Machine.

Pre-market Notification Details

Device IDK220700
510k NumberK220700
Device Name:Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
ClassificationSystem, X-ray, Mobile
Applicant Yian Medical Technology (Haining) Co., Ltd 1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 Caohejing Road, Haining Economic Development Zone Jiaxing,  CN
ContactZhiqin Yu
CorrespondentZhiqin Yu
Yian Medical Technology (Haining) Co., Ltd 1st Floor Area 1, 2nd Floor Area 1, Building A, No. 2 Caohejing Road, Haining Economic Development Zone Jiaxing,  CN
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-10
Decision Date2022-05-04

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