Yian Medical Technology (Haining) Co., Ltd.

Basic Information

• Brand Name: Yian Medical Technology (Haining) Co., Ltd.
• Primary DI: 06975023416012
• Version / Model: Heart3R-110
• Company Name: Yian Medical Technology (Haining) Co., Ltd.
• Labeler DUNS: 713686549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-27
• Public Version: 1
• Public Version Date: 2022-07-05
• Public Version Status: New
• Public Device Record Key: c89a8864-2c05-4a1b-9f54-cd1584d455f0

Device Description

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 Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZL	System, X-Ray, Mobile	Radiology	892.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37606	Diagnostic x-ray system generator, portable	An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06975023416012	GS1

Premarket Submissions

Submission Number	Supplement Number
K220700	000