Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instruments
Computed tomographs (CT)
EMDN code Z110306
Manufacturers registered in Europe (EUDAMED) 22
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) | China, Netherlands |
|
IIb MDR | eudamed@philips.com EUDAMED record Report an error |
| Ge Hangwei Medical Systems FDA EU representative : GE Medical Systems SCS (France) | China | IIb MDR, 93/42 | eudamed@gehealthcare.com EUDAMED record Report an error | |
| Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR, 93/42 | services@united-imaging.com EUDAMED record Report an error | |
| Anke EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
5 others
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands) | China |
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| SG Healthcare FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | South Korea |
|
IIb 93/42 | Website info@sghealthcare.com EUDAMED record Report an error |
| GE Healthcare FDA EU representative : GE Medical Systems SCS (France) | India, Japan | IIb MDR, 93/42 | eudamed@gehealthcare.com EUDAMED record Report an error | |
| Vatech FDA EU representative : VATECH GLOBAL FRANCE SARL (France) | South Korea | IIb MDR, 93/42 | Website EUDAMED record Report an error | |
| Beijing Wandong Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR | EUDAMED record Report an error | |
| Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) | Japan | IIb MDR | EUDAMED record Report an error | |
| GE Medical Systems FDA EU representative : GE Medical Systems SCS (France) | United States | IIb MDR | eudamed@gehealthcare.com EUDAMED record Report an error | |
| KuanTeng (Beijing) Medical Technology EU representative : Lotus NL B.V. (Netherlands) | China | IIb MDR | EUDAMED record Report an error | |
| Minfound EU representative : MedNet EC-REP C IIb GmbH (Germany) | China |
|
IIb 93/42 | Info@minfound.com EUDAMED record Report an error |
| Siemens Healthcare FDA | Germany | IIb MDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Siemens Healthineers FDA | Germany | IIb MDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Siemens Shanghai Medical Equipment EU representative : Siemens Healthcare GmbH (Germany) | China |
|
IIb MDR | Website contact@siemens-healthineers.com EUDAMED record Report an error |
| SinoVision Healthcare (Yangzhou) EU representative : MedPath GmbH (Germany) | China | IIb MDR | EUDAMED record Report an error | |
| Canon FDA EU representative : Canon Medical Systems Europe B.V. (Netherlands) | Japan |
|
IIb MDR | eudamed-info@mail.canon EUDAMED record Report an error |
| Meyerop FDA EU representative : MedPath GmbH (Germany) | China | IIb MDR | EUDAMED record Report an error | |
| Nanjing Anke Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIb MDR | EUDAMED record Report an error |
| Osstem FDA EU representative : Obelis s.a. (Belgium) | South Korea |
|
IIb MDR | EUDAMED record Report an error |
| Wipro Ge Medical Device Manufacturing EU representative : GE Medical Systems SCS (France) | India | IIb MDR | eudamed@gehealthcare.com EUDAMED record Report an error |
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) 163
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 |
|---|---|---|---|
| Izi Medical Products, LLC Present in Europe in other categories | United States | VISICOIL VISICOIL MR Gold Fiducial | registered |
| Neurologica Corporation | United States | OmniTom Elite PCD CT SCANNER , NL3000 ELITE, RAIL/PLATE CONFIG Transfer Board Assembly Stryker Bed Adapter OPTION, EXTENDED HILL-ROM PROGRESSA PULMONARY SCAN BOARD STRYKER POWERPRO X AMBULANCE SCAN BOARD W/ LATCH LOCK | K250928 (2025) |
| Covidien, LLC Present in Europe in other categories | United States | ILLUMISITE Edge superDimension SuperLock | K191394 (2019) |
| Canon Medical Informatics, Inc. Present in Europe in other categories | United States | Vitrea Advanced Visualization Vitrea | K252217 (2025) |
| Qfix Present in Europe in other categories | United States | InfinityLock™ Alta Encompass™ Leg Extension Symphony™ Alpine Stirrups | registered |
| Auris Health, Inc. | United States | Monarch Bronchscope 2.0/Monarch Platform (P2) Monarch Software Tower v2.1.6 Monarch™ Tower Software v4.1.1 MONARCH™ Planning Laptop Software P17/P73 Linux USB Image MONARCH™ Tower Software Monarch™ Platform | registered |
| Bracco Injeneering SA Present in Europe in other categories | Switzerland | EmpowerSync® Power Supply Injector Mounting Arm, Right Injector Head Injector Mounting Arm, Left Floor Stand Remote Control | registered |
| G E MEDICAL SYSTEMS ISRAEL LTD. | Israel | Discovery NMCT 830 to 850 Upgrade 830 to 860 Upgrade StarGuide 830 to 870 DR Upgrade | registered |
| Imbio, LLC | United States | Imbio LDA Imbio Freya Imbio CAC | K230112 (2023) |
| Xact Robotics, Ltd. | Israel | Respiration Sensor Drape XACT ACE Xtend XACT Robotics: 19g Needle Threading Jig Frame-Harness Strap Set XACT Robotics: Harness (S) XACT Robotics: Robot Drape | K213759 (2022) |
| Ischemaview, Inc. Present in Europe in other categories | United States | Rapid | K262301 (2026) |
| Brainomix Limited Present in Europe in other categories | United Kingdom | e-Lung Brainomix 360 e-Lung Triage LVO Triage Stroke Triage ICH | K242411 (2025) |
| LODOX SYSTEMS (PTY) LTD | United States | LODOX | K013999 (2002) |
| Brainlab AG Present in Europe in other categories | Germany | Brainlab Elements Contouring Brainlab Elements Image Fusion Brainlab Elements Fibertracking Brainlab Elements BOLD MRI Mapping Image Fusion Fibertracking | K113732 (2012) |
| Riverain Technologies, Inc. Present in Europe in other categories | United States | ClearRead CT CAC Docker ClearRead CT CAC Console ClearRead CT CAC Server | K242188 (2024) |
| Coreline Soft Co., Ltd. Present in Europe in other categories | South Korea | AVIEW AVIEW CAC AVIEW LCS | K260391 (2026) |
| CLEAR GUIDE MEDICAL, INC. Present in Europe in other categories | United States | Clear Guide CORE Clear Guide SCENERGY Clear Guide SCENERGY TP Clear Guide Optical Head | K234030 (2024) |
| HARRISON-AI MEDICAL PTY LTD Present in Europe in other categories | Australia | Annalise Triage Annalise Enterprise Annalise Critical Care AI | K253818 (2026) |
| IMACTIS Present in Europe in other categories | France | IMACTIS® | K162314 (2018) |
| Spectrum Dynamics Medical, Ltd. Present in Europe in other categories | Israel | VERITON CT | registered |
| UIH TECHNOLOGIES LLC | United States | uCT uMI VM uMI | registered |
| Aidoc Medical , Ltd. Present in Europe in other categories | Israel | BriefCase Triage | K261317 (2026) |
| Quantum Surgical Sas Present in Europe in other categories | France | EPIONE Needle Guide Patient Reference Short Navigation Probe | K223758 (2023) |
| Varian Medical Systems, Inc. Present in Europe in other categories | United States | Respiratory Gating for Scanners (RGSC) Respiratory Gating for Scanners Visual Coaching Device (VCD) Gating Reflector Block | K253026 (2026) |
| Avicenna.Ai Present in Europe in other categories | France | CINA-CSpine CINA-iPE CINA CINA CHEST | K240942 (2024) |
| GE Hualun Medical Systems Co., Ltd Present in Europe in other categories | China | Brivo 615 D630 to D670 DR Upgrade Revolution | registered |
| Icad, Inc. | United States | VeraLook CTC CAD | K091529 (2010) |
| SONY CORPORATION | Japan | SONY | registered |
| Analogic Corp. | United States | Analogic ImpaCT | K201231 (2021) |
| Arineta , Ltd. Present in Europe in other categories | Israel | SpotLight Duo SpotLight CardioGraphe | K250650 (2025) |
| CEFLA SOCIETA' COOPERATIVA | – | NewTom | registered |
| Cascination AG Present in Europe in other categories | Switzerland | CAS-One IR CAS-One IR Software CAS-One IR Consumable Set General | K261225 (2026) |
| JLK, Inc. | South Korea | JLK-ICH JLK-SDH JLK-LVO | K252421 (2026) |
| Neocoil, LLC Present in Europe in other categories | United States | ECG CT Gating Cable ECG CT Gating Receiver ECG CT Gating Device | K160350 (2016) |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | Biograph Vision Quadra Biograph Trinion.X EP5 CT64 Biograph Trinion.X EP5 CT128 | K253574 (2026) |
| Viatronix, Inc. | United States | V3D-Calcium Scoring V3D-Cardiac | K083293 (2008) |
| Vida Diagnostics, Inc. | United States | VIDA Insights VIDA|vision LungPrint | K200990 (2020) |
| Viz. Ai, Inc. Present in Europe in other categories | United States | Viz LVO Viz ICH Viz SDH (Viz Subdural) | K223042 (2022) |
| BunkerHill Health | United States | iCAC Device CAC (Gated) Algorithm | K260167 (2026) |
| Carestream Health, Inc. Present in Europe in other categories | United States | OnSight 3D Extremity System | K173478 (2018) |
| Isys Medizintechnik GmbH Present in Europe in other categories | Austria | Micromate Micromate Navi+ | K230130 (2023) |
| MAXQ AI LTD | – | AccipioIx | registered |
| NANO-X AI LTD Present in Europe in other categories | Israel | HealthICH | registered |
| NICo-Lab B.V. Present in Europe in other categories | Netherlands | StrokeViewer LVO Triaging StrokeViewer Perfusion | K211788 (2021) |
| Thirona BV | Netherlands | LungQ® | K250766 (2025) |
| Ziehm Imaging GmbH Present in Europe in other categories | Germany | Ziehm Vision RFD 3D Ziehm Vision2 FD | K073346 (2008) |
| AGILITI HEALTH, INC. | – | Z-DOSE29 | registered |
| Circle Neurovascular Imaging Inc | Canada | StrokeSENS | K212261 (2021) |
| EDDA TECHNOLOGY, INC. Present in Europe in other categories | United States | EDDA TECHNOLOGY | K151414 (2015) |
| EPICA HUMAN HEALTH LLC | – | See Factor CT3 | registered |
| Heuron Co., Ltd. Present in Europe in other categories | South Korea | Heuron ICH | K233247 (2024) |
| IB Lab GmbH Present in Europe in other categories | Austria | KOALA | registered |
| IMRIS Imaging, Inc. Present in Europe in other categories | United States | iCT | registered |
| Imaging Biometrics, LLC Present in Europe in other categories | United States | LSN | K201092 (2020) |
| MEDIC VISION - IMAGING SOLUTIONS LTD | Israel | SafeCT-29 | K153331 (2016) |
| MULTIFUNCTIONAL IMAGING, LLC | United States | mfiVerse | registered |
| Median Technologies | United States | LMS-Lung/TRACK | registered |
| Medtec, Inc. Present in Europe in other categories | United States | ZiFix Traverse | registered |
| Mobius Imaging, LLC | United States | Airo® | K180393 (2018) |
| NEUROCAREAI INC | United States | NeuroICH | K241719 (2024) |
| NVIEW MEDICAL INC. | United States | nView s1 with nav option | registered |
| PERFINT HEALTHCARE PRIVATE LIMITED | – | MAXIO | registered |
| PULMONX CORPORATION | United States | Lung Image Analysis | K212494 (2021) |
| Planmed OY Present in Europe in other categories | Finland | Planmed | K121418 (2013) |
| QURE.AI TECHNOLOGIES PRIVATE LIMITED Present in Europe in other categories | India | qER | registered |
| Radiobotics ApS Present in Europe in other categories | Denmark | RBknee | registered |
| Ziosoft, Inc. Present in Europe in other categories | United States | Ziostation2 | registered |
| 20MED PTE LTD | Singapore | – | registered |
| 4Dx Limited | Australia | – | K193293 (2020) |
| A2z Radiology Ai, Inc. Present in Europe in other categories | United States | – | K260906 (2026) |
| AGITO Medical A/S | Denmark | – | registered |
| ANDA Medical | Canada | – | registered |
| Acist Medical Systems, Inc. Present in Europe in other categories | United States | – | registered |
| Alken, Inc. d/b/a Polhemus | United States | – | registered |
| Annalise-Ai Pty , Ltd. | Australia | – | K231384 (2023) |
| Bayer Medical Care Inc. Present in Europe in other categories | United States | – | registered |
| Biomerics | United States | – | registered |
| Block Imaging SAS | United States | – | registered |
| Bunkerhill, Inc. | United States | – | K230223 (2023) |
| CIS Computerised Imaging Services Pty Ltd | Australia | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| Change Healthcare Canada Company Present in Europe in other categories | Canada | – | registered |
| Curacloud Corp. | United States | – | K192167 (2020) |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Deep01 Limited | Taiwan | – | K182875 (2019) |
| Elekta , Ltd. Present in Europe in other categories | United Kingdom | – | registered |
| Epica International, Inc. | United States | – | registered |
| Ever Fortune.Ai, Co., Ltd. | Taiwan | – | K263109 (2026) |
| EverX / Bindra | Australia | – | registered |
| Everx Japan Co. Ltd | Japan | – | registered |
| FLEXRAY MEDICAL | Denmark | – | registered |
| FUJITA CO., LTD. | Japan | – | registered |
| Fair Medical Co.,Ltd | Japan | – | registered |
| Field Three Corporation | Japan | – | registered |
| Fluidda, Inc. Present in Europe in other categories | United States | – | K191550 (2020) |
| Fmi Medical Systems, Inc. | United States | – | K192590 (2020) |
| Ge Hangwei Medical System Co., Ltd. | China | – | K153429 (2016) |
| Gef Medical Systems Scs | France | – | K163281 (2017) |
| Gexpro, A Division of Rexel USA, Inc. | United States | – | registered |
| Gsell Medical Plastics AG | Switzerland | – | registered |
The 100 most active manufacturers are shown, out of 163.
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