Manufacturer

Canon

JapanLegal entities : Canon Inc.

Markets : Austria · Belgium · France · Germany · Italy · Netherlands · Northern Ireland · Portugal · Spain · UK · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 189 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 72 · Spain 50 · Belgium 18 · Germany 17 · Portugal 7 · Netherlands 6 · Austria 4 · Italy 4 · UK 1

EU representative : Canon Medical Components Europe B.V. (Netherlands)

eudamed-info@mail.canon

12 categories, 16 models including 16 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Multifunctional systems for direct digital radiology	Z11031101	DIGITAL RADIOGRAPHY CXDI-402C Wireless3 refs DREX-UI80 FLAT PANEL DETECTOR AF-B13 refs	I, IIa, IIb MDR	EUDAMED record Report an error
Ophthalmometers	Z12120113	Full Auto Ref-Keratometer RK-F3m Optical Coherence Tomography ALTA Duo 3003 refs	IIa MDR	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - medical device software	Z119092	VSTP-002A, CUW-U001S, etc.3 refs XIDF-AWS802	IIa MDR	EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field less than or equal to 2t	Z11050104	MRT-3020, MRT-1550, etc.3 refs	IIa MDR	EUDAMED record Report an error
Computed tomographs - 16 layers or more but less than 64 layers	Z11030603	TSX-501A, TSX-308A, etc.3 refs	IIb MDR	EUDAMED record Report an error
Multidisciplinary ultrasound scanners (internal and cardiology, etc.)	Z11040104	CUS-ABE00, CUS-AME00, TUS-AI900, etc.3 refs	IIa MDR	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - medical device software	Z12120192	Ophthalmic Software Platform RX(RX Capture for Retinal Camera, RX Server, RX Viewer)	IIa MDR	EUDAMED record Report an error
Ophthalmoscopes	Z12120114	Digital Retinal Camera CR-103 refs	I MDR	EUDAMED record Report an error
Stationary angiography systems for angiographic and cardiologic studies	Z11030102	INFX-8000C, INFX-8000F, etc.3 refs	IIb MDR	EUDAMED record Report an error
Tonometers	Z12120122	Full Auto Tonometer TX-20	IIa MDR	EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes	Z110402010101	PSI-28VX, PET-835LA, PVU-475BT, etc.3 refs	IIa MDR	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - other	Z119099	SWRA-BSA	I MDR	EUDAMED record Report an error

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