Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsVarious instruments for radiodiagnostics and interventional procedures
X-ray tube assembly
EMDN code Z11039012
Manufacturers registered in Europe (EUDAMED) 18
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 33
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA Present in Europe in other categories | – | RTC 1000 HS RTM 90 HS RTM 101 HS RTC 700 HS RTM 101 H RTM 90 H | registered |
| Wuxi Guochen Medical Technology Co., Ltd. | China | Medical CT X-Ray Tube Medical CT X-Ray Tube Assembly Medical Diagnostic Rotating Anode X-Ray Tube Medical Diagnostic Rotating Anode X-Ray Tube Assembly | registered |
| MingWei Medical Technology(Suzhou)Co.,LTD | China | Mingwei | registered |
| Beijing Smartbeam Medical Devices Co.,LTD | China | Medical CT X-ray tube assembly Medical diagnostic rotating anode X-ray tube | registered |
| Beijing Smartbeam Technology Co., LTD | – | SMARTBEAM | registered |
| Source-Ray, Inc. | United States | XRS-140-7.5K-P XRS-125-7K-P SB-80-200R SB-60-333 XRS-140-15K-P | registered |
| Richardson Electronics, Ltd. | United States | Richardson Electronics | registered |
| Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd Present in Europe in other categories | China | S Spellman High Voltage Electronics Corporation | registered |
| Amirix Imaging LLC | United States | Amirix Imaging | registered |
| GE Healthcare Present in Europe in other categories | United States | – | registered |
| GE Healthcare Austria GmbH & Co OG Present in Europe in other categories | – | Voluson | registered |
| GE Medical Systems Ultrasound and Primary Care Diagnostics Present in Europe in other categories | United States | LOGIQ | registered |
| AGITO Medical A/S | Denmark | – | registered |
| Arquilla, Inc. Dba X-Cel X-Ray Corporation | United States | – | registered |
| Block Imaging SAS | United States | – | registered |
| CIS Computerised Imaging Services Pty Ltd | Australia | – | registered |
| FUJITA CO., LTD. | Japan | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| GST CORPORATION LIMITED Present in Europe in other categories | India | – | registered |
| Gilardoni S.P.A. Present in Europe in other categories | Italy | – | registered |
| IAE SPA Present in Europe in other categories | Italy | – | registered |
| Konason (Guangdong) Medical Imaging Technology Co., Ltd | China | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| Medical Resale PTY Limited | Australia | – | registered |
| Micro X-ray technology (Suzhou) Co., Ltd | China | – | registered |
| SHINYOUNG FOR M CO.,LTD. Present in Europe in other categories | South Korea | – | registered |
| SPELLMAN HIGH VOLTAGE ELECTRONICS CORP. Present in Europe in other categories | United States | – | registered |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | registered |
| Tromp Medical | Netherlands | – | registered |
| WUXI YUSHOU MEDICAL APPLIANCES CO.,LTD. | China | – | registered |
| X-Ray America, LLC | United States | – | registered |
| Zhuhai Niray Photon Technology Co., Ltd. | China | – | registered |
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