Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsComputed tomographs (CT)
Computed tomographs (CT) - software accessories
EMDN code Z11030682
Manufacturers registered in Europe (EUDAMED) 9
- 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) 32
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 |
|---|---|---|---|
| Ischemaview, Inc. Present in Europe in other categories | United States | Rapid | K262301 (2026) |
| Brainomix Limited Present in Europe in other categories | United Kingdom | Triage LVO Triage Stroke Triage ICH | K251983 (2025) |
| HARRISON-AI MEDICAL PTY LTD Present in Europe in other categories | Australia | Annalise Triage Annalise Enterprise Annalise Critical Care AI | K253818 (2026) |
| Aidoc Medical , Ltd. Present in Europe in other categories | Israel | BriefCase Triage | K261317 (2026) |
| Avicenna.Ai Present in Europe in other categories | France | CINA-CSpine CINA-iPE CINA CINA CHEST | K240942 (2024) |
| JLK, Inc. | South Korea | JLK-ICH JLK-SDH JLK-LVO | K252421 (2026) |
| Viz. Ai, Inc. Present in Europe in other categories | United States | Viz LVO Viz ICH Viz SDH (Viz Subdural) | K223042 (2022) |
| 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) |
| Circle Neurovascular Imaging Inc | Canada | StrokeSENS | K212261 (2021) |
| Heuron Co., Ltd. Present in Europe in other categories | South Korea | Heuron ICH | K233247 (2024) |
| NEUROCAREAI INC | United States | NeuroICH | K241719 (2024) |
| QURE.AI TECHNOLOGIES PRIVATE LIMITED Present in Europe in other categories | India | qER | registered |
| A2z Radiology Ai, Inc. Present in Europe in other categories | United States | – | K260906 (2026) |
| Annalise-Ai Pty , Ltd. | Australia | – | K231384 (2023) |
| Curacloud Corp. | United States | – | K192167 (2020) |
| Deep01 Limited | Taiwan | – | K182875 (2019) |
| Ever Fortune.Ai, Co., Ltd. | Taiwan | – | K263109 (2026) |
| GuideAI Health | United States | – | K260729 (2026) |
| Maxq-Al , Ltd. | Israel | – | K201310 (2020) |
| Methinks Software, S.L Present in Europe in other categories | Spain | – | K251590 (2025) |
| Mlhealth 360 | Canada | – | K250694 (2025) |
| Nines, Inc. | United States | – | K193351 (2020) |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | registered |
| Purple AI Inc. | South Korea | – | registered |
| Qure.Ai Technologies | India | – | K251610 (2025) |
| Shanghai United Imaging Intelligence Co., Ltd. Present in Europe in other categories | China | – | K242292 (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 | – | K243145 (2025) |
| Viz.Al, Inc. | United States | – | registered |
| Zebra Medical Vision, Ltd. | Israel | – | K190424 (2019) |
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Related categories
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- Parent category : Computed tomographs (CT)22 manufacturers