Yian Medical Technology (Haining) Co., Ltd.

Address:1st Floor Area 1,2nd Floor Area 1,Building A, No. 2 Caohejing Road, Haining Economic Development Zone,,Jiaxing City, Zhejiang,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, X-Ray, Mobile (IZL) (2)

Premarket Exempt

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Yian Medical Technology (Haining) Co., Ltd. - 06975023416012 Catalog Number :

Device Description : The Heart3R-110 is Portable X-ray Machine, intended for use by a qualified/train The Heart3R-110 is Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).The system is subject to the following limitations of use when stand-mounted:- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.-The device may be used for imaging of the chest when used without a grid.This device is not intended for mammography.

Device Class : 2

Duns Number: 713686549

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

Yian Medical Technology (Haining) Co., Ltd. - 06975023416029 Catalog Number :

Device Description : The Heart5R-110 is Portable X-ray Machine, intended for use by a qualified/train The Heart5R-110 is Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).The system is subject to the following limitations of use when stand-mounted:- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.-The device may be used for imaging of the chest when used without a grid.This device is not intended for mammography.