Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instruments
Multifunctional systems for traditional radiology
EMDN code Z110310
Manufacturers registered in Europe (EUDAMED) 13
- 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) 82
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 |
|---|---|---|---|
| Carestream Health, Inc. Present in Europe in other categories | United States | DRX - Ascend System Q-RAD System DRX-Evolution Plus System CARESTREAM DRX-EVOLUTION CARESTREAM DRX-EVOLUTION Plus DRX-Compass X-ray System | K250954 (2026) |
| Shimadzu Corp. Present in Europe in other categories | United States | RADspeed Pro FDR Visionary Suite RADspeed fit | K233719 (2024) |
| GE Hualun Medical Systems Co., Ltd Present in Europe in other categories | China | Definium Discovery Optima Proteus Brivo | K250788 (2025) |
| Octostop, Inc. | Canada | Boomerang Velcro Strap For Prism Prism External Right Velcro Strap for Ridges Ridges Plus | K972766 (1997) |
| Radmedix, LLC | United States | AcuitySDR Radmedix Radmedix AcuityUDR Radmedix AcuityFDR Radmedix AcuityFDR+ Radmedix AcuitySDR | K231995 (2023) |
| Sedecal., Sa. Present in Europe in other categories | United States | SEDECAL | K203537 (2021) |
| KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. | – | Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad KDR Floor Mount+ System Advanced Universal U-Arm Stand 3000 KDR DDR Primary U Arm 2020i Imaging Hand System Overhead Tube Crane Ceiling Suspension | registered |
| DRTECH Corporation Present in Europe in other categories | South Korea | EXSYS DEXi FLAATZ | K260227 (2026) |
| ARQUILLA, INC. | – | X-CEL X-RAY CORPORATION | registered |
| Del Medical, Inc. | United States | Del Medical, Inc. | K223550 (2023) |
| Imaging Dynamics Company , Ltd. | Canada | Xplorer 2200 Digital Radiographic System X3C 1600 Plus Digital Radiographic System X3C 1600 Digital Radiographic System X3C 1100 Digital Radiographic System Xplorer 1500 Digital Radiographic System Xplorer 1590 Digital Radiographic System | K071401 (2007) |
| Siemens Shanghai Medical Equipment Ltd. Present in Europe in other categories | – | MULTIX Impact Multix DR-Upgrade KIT VA20 Multix Fusion VA30 Multix Fusion VA40 MULTIX Impact E MULTIX SELECT DR | registered |
| Samsung Electronics Co., Ltd. Present in Europe in other categories | South Korea | – | K260481 (2026) |
| Agfa Corp. Present in Europe in other categories | United States | DX-D 600 DX-D 400 DX-D 300 | registered |
| Philips Medical Systems Dmc GmbH Present in Europe in other categories | Germany | DigitalDiagnost DigitalDiagnost C90 Precision CRF Radiography 7300 C ProxiDiagnost N90 | K233662 (2024) |
| Jpi Healthcare Co, Ltd. Present in Europe in other categories | South Korea | DRE Duo ExamVue Box for ExamVue DR(outside 265mmx185mmx150mm) | K260482 (2026) |
| Cmt Medical Technologies, Ltd. Present in Europe in other categories | Israel | ArtPix Fixed Lite Presto DR 4343Optimum ArtPiX Mobile EZ2GO ArtPix Mobile Lite Presto DR 4143Optimum Presto DR 3543 EZ Optimum | K162224 (2016) |
| Konica Minolta, Inc. Present in Europe in other categories | Japan | AeroDR Stitching Barrier Unit AeroDR X70 AeroDR 0170CS AeroDR S33/S30 AeroDR T50 | registered |
| Shanghai United Imaging Healthcare Co., Ltd. Present in Europe in other categories | China | uDR | K252000 (2025) |
| Eos Imaging Present in Europe in other categories | France | EOS® EOSedge™ EOSedge | K233920 (2024) |
| Osko, Inc. | United States | DCX XR5 RU3000 ELIAN | K150663 (2015) |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | YSIO X.pree MOBILETT Impact Ysio Max | registered |
| VISARIS DOO Present in Europe in other categories | Serbia | VISION | registered |
| Arcoma AB | Sweden | OMNERA 400A OMNERA 400T OMNERA 500A | K140683 (2014) |
| XORAN TECHNOLOGIES LLC Present in Europe in other categories | United States | MiniCAT 2D | K201825 (2020) |
| Kubtec Present in Europe in other categories | – | KUBTEC XPERT20 | registered |
| Prognosys Medical Systems Private Limited Present in Europe in other categories | India | PRORAD 3NC PRORAD 2FC | K183541 (2019) |
| SKANRAY TECHNOLOGIES LIMITED Present in Europe in other categories | India | SKANRAD 400 PodSKAN HF Diagnostic X-ray System | K231761 (2023) |
| Swissray Medical AG | United States | ddR Element ddR Formula Plus | K110828 (2011) |
| UIH TECHNOLOGIES LLC | United States | uDR | registered |
| XERA TEKNOLOJI VE YAZILIM LIMITED SIRKETI | – | GR10X | registered |
| Biokinemetrics, Inc. | United States | BIOK-4600 | registered |
| Bracco Diagnostics Inc. Present in Europe in other categories | United States | Fast Find Grid: Disposable CT Biopsy Grid | registered |
| CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság | – | Z-MOTION | registered |
| Communications & Power Industries Canada, Inc. | Canada | CPI RAD VISION | K122726 (2013) |
| Cuattro Medical | – | CuattroDR | registered |
| GE Medical Systems Present in Europe in other categories | United States | Definium | K103448 (2011) |
| GEMSS MEDICAL SYSTEMS CO.,LTD. | United States | SYSTEM, X-RAY, STATIONARY | K133695 (2014) |
| Halifax Biomedical Incorporated | United States | Halifax Imaging Kit | K182880 (2018) |
| Medicatech USA | United States | MasteRad | K190601 (2019) |
| NANORAY BIOTECH CO., LTD. Present in Europe in other categories | Taiwan | RevoluX | K220271 (2022) |
| Source-Ray, Inc. | United States | PXS-710D | K133959 (2015) |
| THALES AVS FRANCE SAS Present in Europe in other categories | France | ArtPiX Mobile EZ2GO | registered |
| Adani | Belarus | – | K200944 (2020) |
| Allengers Medical Systems Limited Present in Europe in other categories | India | – | K223060 (2022) |
| Arquilla, Inc. Dba X-Cel X-Ray Corporation | United States | – | K160857 (2017) |
| Aspen Imaging Healthcare, Inc. | United States | – | registered |
| Block Imaging SAS | United States | – | registered |
| CMR X-Ray, LLC | United States | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. | Mexico | – | K193637 (2020) |
| Cuattro Imaging, LLC | United States | – | registered |
| Cuattro, LLC | United States | – | K161937 (2016) |
| DAEIL PRECISION INDUSTRY CO.,LTD | South Korea | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Dk Medical System | South Korea | – | K242119 (2025) |
| EverX / Bindra | Australia | – | registered |
| Fair Medical Co.,Ltd | Japan | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| H&abyz Co., Ltd. Present in Europe in other categories | South Korea | – | registered |
| Konica Minolta Healthcare Americas, Inc. Present in Europe in other categories | United States | – | K221853 (2022) |
| Kub Technologies, Inc. Present in Europe in other categories | United States | – | K083510 (2009) |
| Kuehne GmbH | Germany | – | registered |
| Livermoretech, Inc. | United States | – | K180663 (2018) |
| Medical Resale PTY Limited | Australia | – | registered |
| Medivest Group | United Kingdom | – | registered |
| Orich Medical Equipment (Tianjin) Co., Ltd. | China | – | K152813 (2016) |
| PROBO Medical SAS | France | – | registered |
| Pausch Corp. | United States | – | K790741 (1979) |
| Philips Healthcare (Suzhou) Co., Lit. | China | – | K201725 (2020) |
| Philips Healthcare (Suzhou) Co., Ltd. Present in Europe in other categories | China | – | K201640 (2020) |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | K931071 (1994) |
| Prognosys Medical Systems | India | – | registered |
| Shenzhen Sontu Medical Imaging Equipment Co., Ltd. Present in Europe in other categories | China | – | K242499 (2025) |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | K260488 (2026) |
| Summit Industries, Inc. Present in Europe in other categories | United States | – | K173823 (2018) |
| Televere Systems | United States | – | K180765 (2018) |
| Visaris D.O.O. Belgrade | Serbia | – | K160620 (2016) |
| Vmi Tecnologias Ltda | Brazil | – | K202388 (2020) |
| XERA Medikal Sistemleri ve Teknoloji Ltd. Sti. | Türkiye | – | registered |
| Xera Medical Systems & Technology , Ltd. Present in Europe in other categories | Türkiye | – | K220149 (2022) |
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