Yian Medical Technology (Haining) Co., Ltd.

GUDID 06975023416029

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.

Yian Medical Technology (Haining) Co., Ltd.

Diagnostic x-ray system generator, portable Diagnostic x-ray system generator, portable Diagnostic x-ray system generator, portable Diagnostic x-ray system generator, portable Diagnostic x-ray system generator, portable Diagnostic x-ray system generator, portable Diagnostic x-ray system generator, portable Diagnostic x-ray system generator, portable

• Primary Device ID: 06975023416029
• NIH Device Record Key: 6d0a4d4b-aaee-4db8-95db-362e99be68b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Yian Medical Technology (Haining) Co., Ltd.
• Version Model Number: Heart5R-110
• Company DUNS: 713686549
• Company Name: Yian Medical Technology (Haining) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975023416029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220700

FDA Product Code

• IZL: System, X-Ray, Mobile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-05
• Device Publish Date: 2022-06-27

On-Brand Devices [Yian Medical Technology (Haining) Co., Ltd.]

• 06975023416029: The Heart5R-110 is Portable X-ray Machine, intended for use by a qualified/trained physician or
• 06975023416012: The Heart3R-110 is Portable X-ray Machine, intended for use by a qualified/trained physician or