Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsVarious instruments for radiodiagnostics and interventional procedures
Mobile radiographic units
EMDN code Z11039016
Manufacturers registered in Europe (EUDAMED) 41
- 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) 59
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 |
|---|---|---|---|
| Minxray, Inc. | United States | MinXray | K210479 (2021) |
| Radmedix, LLC | United States | AcuityPDR Radmedix AcuityPDR+ Radmedix AcuityPDR | K200726 (2020) |
| OXOS Medical, Inc. | United States | MC2 Portable X-ray System Micro C Medical Imaging System, M01 OXBox Cart Micro C Medical Imaging System, M01 Foot Pedal Micro C Load Bearing Cassette Plate, ACSY-S009 | K212654 (2022) |
| Shimadzu Corp. Present in Europe in other categories | United States | MobileDaRt Evolution FDR Go Mobirex i9 MobileArt Evolution | K090268 (2009) |
| DRGEM Corporation Present in Europe in other categories | South Korea | DRGEM | K260085 (2026) |
| Source-Ray, Inc. | United States | SR-1260-G SR-1260-C RC-115 UC-5000 SR-115-CG SR-130-C | K163063 (2016) |
| ECOTRON Present in Europe in other categories | South Korea | – | K151038 (2015) |
| AJEX Meditech Ltd | United States | Portable X-ray Unit | K122298 (2014) |
| Aribex, Inc. | United States | NOMAD MD™ handheld X-ray system | K140723 (2014) |
| Agfa Corp. Present in Europe in other categories | United States | DX-D 100 DR 100s | K191884 (2019) |
| ALPHA SOURCE INC. | – | ALPHA SOURCE BATTERY | registered |
| First Source, Inc. | United States | iQ Flex iQ View | K240009 (2024) |
| KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | – | Portable X-Ray System | registered |
| Samsung Electronics Co., Ltd. Present in Europe in other categories | South Korea | – | K242651 (2024) |
| XORAN TECHNOLOGIES LLC Present in Europe in other categories | United States | xCAT xCAT IQ xCAT XL | registered |
| Del Medical, Inc. | United States | Del Medical, Inc. | K173018 (2017) |
| NEUF Inc. | South Korea | X-RAY | K230581 (2023) |
| Yian Medical Technology (Haining) Co., Ltd. | China | Yian Medical Technology (Haining) Co., Ltd. | K220700 (2022) |
| CANYON RIDGE RESOURCES LIMITED LIABILITY COMPANY | – | Spectre | registered |
| JOB CORPORATION | United States | PORTA | K122697 (2012) |
| Kubtec Present in Europe in other categories | – | KUBTEC | registered |
| Shanghai United Imaging Healthcare Co., Ltd. Present in Europe in other categories | China | uDR | K242515 (2024) |
| Swissray Medical AG | United States | ddR Cruze | registered |
| VATECH Co., Ltd. Present in Europe in other categories | United States | EzRay M | K213462 (2022) |
| ANDA Medical | Canada | – | registered |
| Arquilla, Inc. Dba X-Cel X-Ray Corporation | United States | – | registered |
| Aspen Imaging Healthcare, Inc. | United States | – | registered |
| Aspenstate, Inc. | United States | – | K220678 (2022) |
| Block Imaging SAS | United States | – | registered |
| Bontech, Inc. Present in Europe in other categories | South Korea | – | K243864 (2025) |
| Can Technomed Trading LTD. | Canada | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| DRTECH Corporation Present in Europe in other categories | South Korea | – | registered |
| Energy Resources International Co., Ltd. | Taiwan | – | K234108 (2024) |
| EverX / Bindra | Australia | – | registered |
| FSK Co., Ltd | South Korea | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | K042866 (2004) |
| GEMSS HEALTHCARE CO., LTD. Present in Europe in other categories | South Korea | – | K260236 (2026) |
| HUESTIS MACHINE CORPORATION | United States | – | K181874 (2018) |
| Hdt Co., Ltd. | South Korea | – | K213405 (2022) |
| Kub Technologies, Inc. Present in Europe in other categories | United States | – | K141539 (2014) |
| Livermoretech, Inc. | United States | – | K244049 (2025) |
| Medical Resale PTY Limited | Australia | – | registered |
| Meridian Medical Systems, LLC Present in Europe in other categories | United States | – | K162687 (2016) |
| Mikasa X-Ray Co., Ltd. | United States | – | K060566 (2006) |
| Nano-X Imaging , Ltd. | Israel | – | K203782 (2021) |
| PROBO Medical SAS | France | – | registered |
| Prognosys Medical Systems | India | – | registered |
| Remote Technologies, Inc. | United States | – | K912323 (1991) |
| Scandinavian Medical Solutions A/S | Denmark | – | registered |
| Shenzhen Browiner Tech Co., Ltd. Present in Europe in other categories | China | – | K240841 (2024) |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | K231577 (2023) |
| Soyee Product, Inc. | United States | – | K070634 (2007) |
| Stephanix | France | – | K212515 (2021) |
| Suzhou Powersite Electric Co., Ltd. Present in Europe in other categories | China | – | K222258 (2022) |
| The Kretchmer Corp. | United States | – | registered |
| UIH TECHNOLOGIES LLC | United States | – | registered |
| Vmi Tecnologias Ltda | Brazil | – | K201340 (2020) |
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