Identity
- Trade Name
- Yian Medical Technology (Haining) Co., Ltd. FDA UDI
- Generic Name
- Diagnostic x-ray system generator, portable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Heart5R-110 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975023416029 FDA UDI
- 510(k) Number
- K220700 FDA UDI
- FDA Product Code
- IZL FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, portable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic x-ray system generator, portable
Yian Medical Technology (Haining) Co., Ltd. by Yian Medical Technology (Haining) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Diagnostic x-ray system generator, portable.
- Portable X-ray Unit — AJEX Meditech Ltd · Class II
- POSKOM Co., Ltd. — Poskom Co., Ltd. · Class II
- AirRay — Poskom Co., Ltd. · Class II
- Portable X-ray Unit — AJEX Meditech Ltd · Class II
- DHX-70H — Digimed Corporation · Class II
- POSKOM Co., Ltd. — Poskom Co., Ltd. · Class II
- AirRay — Poskom Co., Ltd. · Class II
- xm-lite — Digimed Corporation · Class II
Cleared under the same submission
K220700 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yian Medical Technology (Haining) Co., Ltd.
Sources (1)
- FDA UDI 6d0a4d4b-aaee-4db8-95db-362e99be68b9 34 fields · synced May 30, 2026