Question 1

What types of medical devices does Beijing Smartbeam Medical Devices Co., LTD primarily manufacture?

Accepted Answer

Beijing Smartbeam Medical Devices Co., LTD specializes in manufacturing X-ray system tubes, specifically medical CT X-ray tube assemblies and medical diagnostic rotating anode X-ray tubes. These devices serve as the radiation source in computed tomography (CT) scanners and diagnostic X-ray machines, enabling high-quality imaging for medical diagnostics.

Question 2

Where is Beijing Smartbeam Medical Devices Co., LTD based?

Accepted Answer

The company is based in the United States. This location ensures compliance with U.S. regulatory standards for the manufacturing and distribution of its medical imaging components.

Question 3

In which regulatory registries are Beijing Smartbeam Medical Devices Co., LTD’s devices listed?

Accepted Answer

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory and market surveillance purposes.

Question 4

How are Beijing Smartbeam Medical Devices Co., LTD’s devices classified under regulatory frameworks?

Accepted Answer

The company’s X-ray system tubes, including CT X-ray tube assemblies and diagnostic rotating anode tubes, are classified as Class I medical devices. This classification is typically assigned to low-risk devices that pose minimal risk to patients and users, though individual device authorization still depends on compliance with applicable regulations.

Device	Model / Reference	Registries	Class	Status
Medical CT X-ray tube assembly	ZS752B/H425A	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS502L/H580C	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS352C	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS702L/H847B	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS352B/H498A	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS702L	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS802L/H560A	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS602L/H560B	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS802B	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS602L	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS502L/H580A	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS502B/H590A	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS352C/H485A	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS632B/H847A	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS802L	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS302B/H580B	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS502L	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS352B	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS602L	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS502B	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS402L/H493A	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS402L	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS712L	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS752B	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS802B/H601A	FDA UDI	Class I	Active
Medical diagnostic rotating anode X-ray tube	ZS302B	FDA UDI	Class I	Active
Medical CT X-ray tube assembly	ZS712L/H485B	FDA UDI	Class I	Active

Beijing Smartbeam Medical Devices Co., LTD

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