Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-Ray Machine
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220700 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Heart5R-110 and Heart3R-110 are portable X-ray machines used to acquire X-ray images of various parts of a patient's anatomy, including the head, cervical spine, chest, abdomen, lumbar spine, pelvis, and extremities. They are designed for use by qualified or trained physicians or technicians on the adult population.
These devices are supplied as portable X-ray machines with a 5kW X-ray power supply. They have a small size, light weight, and high power density, making them suitable for various portable X-ray application scenarios. The devices have been issued FDA 510K clearance.
Frequently asked questions
What is the Heart5R-110 Portable X-Ray Machine used for?
The Heart5R-110 Portable X-Ray Machine is used to acquire X-ray images of various parts of a patient's anatomy, including the head, cervical spine, chest, abdomen, lumbar spine, pelvis, and extremities.
Is the Heart5R-110 Portable X-Ray Machine supplied with any specific power supply?
Yes, the Heart5R-110 Portable X-Ray Machine is supplied with a 5kW X-ray power supply.
What is the regulatory status of the Heart5R-110 Portable X-Ray Machine?
The Heart5R-110 Portable X-Ray Machine has been issued FDA 510K clearance, indicating that it is substantially equivalent to a predicate device.
Who is the intended user of the Heart5R-110 Portable X-Ray Machine?
The Heart5R-110 Portable X-Ray Machine is designed for use by qualified or trained physicians or technicians on the adult population.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine ..., Portable series Heart 5R - IAN Medical, Yian Heart5R-110 Portable X-Ray Heart3R-110… | allmed.wiki, Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220700 | Class II | Active |
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Manufacturer
- Manufacturer
- Yian Medical Technology (Haining) Co., Ltd.
Sources (1)
- FDA 510(k) K220700 24 fields · synced Oct 6, 2026