Manufacturer

Siemens Healthcare

Germany, IndiaLegal entities : Siemens Healthcare GmbH, Siemens Healthcare Pvt. Ltd.

Markets : Belgium · Croatia · Czechia · Denmark · Finland · France · Germany · Greece · Hungary · Ireland · Italy · Luxembourg · Norway · Portugal · Romania · Slovakia · Spain · Sweden · Switzerland · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 38 · class II · latest in 2026 · see on the FDA website

Public contracts won : France 233 · Czechia 50 · Romania 45 · Sweden 44 · Belgium 41 · Italy 40 · Croatia 29 · Germany 24 · Denmark 21 · Finland 20 · Norway 15 · Spain 13 and 7 more countries

EU representative : Siemens Healthcare GmbH (Germany)

Website contact@siemens-healthineers.com

18 categories, 47 models including 44 on the market, 2 countries

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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
Fluoroscopy devices	Z11039009	Article 22 Comb. LUMINOS Q.namix R MDR_SPPP_16_IIb_ERLNH127_Combination_Fluoro3 refs Article 22 Comb. Multitom Rax MDR_SPPP_16_IIb_ERLNH127_Combination_Multitom Article 22 Comb. Uroskop Omnia Max MDR_SPPP_04_IIb_ERLNH127_Combination_Uroskop Luminos Agile Max MDD_16_II b_ERLN H 127_Fluoro_digital_Agile93/42 Luminos dRF Max MDD_16_II b_ERLN H 127_Fluoro_digital_dRF93/42 4 others LUMINOS Lotus Max MDD_16_II b_ERLN H 127_Fluoro_digital_Lotus93/42 LUMINOS Q.namix R MDR_16_II b_ERLN H 127_Fluoro_digital2 refs Multitom Rax MDR_16_II b_ERLN H 127_RF_combi Uroskop Omnia Max MDR_04_II b_ERLN H 127_Uro	IIb MDR, 93/42	EUDAMED record Report an error
Various digital bioimaging management instruments - medical device software	Z11069092	AI Contouring AI-Rad Companion Chest CT MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT AI-Rad Companion Chest X-ray MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CXR2 refs AI-Rad Companion Organs RT MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT2 refs AI-Rad Companion Prostate MR MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_MR-P2 refs 3 others MDD_05_IIa_FOR GmbH_syngo.plaza93/42 Syngo Carbon Clinicals MDR_05_FOR_SYNGO_SaMD_IIb3 refs AI-Rad Companion (Pulmonary) MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_CT-Pulmo (no longer marketed)	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Mobile radioscopic units	Z11039017	Article 22 Comb. CIARTIC MDR_SPPP_01_IIb_FOR_Combination_CIATRIC Article 22 Comb. Cios MDR_SPPP_01_IIb_FOR_Combination_Cios Artikel 22 Comb. Cios Fit MDR_SPPP_01_IIb_BLR_Combination_Cios Fit Cios Alpha MDR_01_IIb_FOR_ACDV_Cios Flow/Alpha/Spin (VA30)3 refs MDR_01_IIb_BLR_ACDV_Cios Fit3 refs 1 other MDR_01_IIb_FOR_ACDV_CIARTIC Move	IIb MDR	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	Article 22 Comb. YSIO X.Pree MDR_SPPP_16_IIb_ERLNH127_Combination_Rad3 refs Ysio Max MDD_16_II b_ERLN H 127_Rad_digital93/42 YSIO X.pree MDR_16_II b_ERLN H 127_Rad_digital3 refs	IIb MDR, 93/42	EUDAMED record Report an error
Stationary angiography systems for angiographic and cardiologic studies	Z11030102	ARTIS genio floor MDR-SHAG_01_IIb_FOR_ACDV_ARTIS explore-genio_floor2 refs ARTIS icono biplane MDR_01_IIb_FOR_ACDV_ARTIS icono/pheno3 refs Artis Q biplane MDR_01_IIb_FOR_ACDV_Artis zee/Q (VD12)3 refs	IIb MDR	EUDAMED record Report an error
Complete cardiography systems	Z12050701	Article 22 Comb. Sensis MDR_SPPP_01_IIb_FOR_Combination_Sensis Sensis Vibe Combo MDR_01_IIb_FOR_ACDV_Sensis Vibe2 refs	IIb MDR	EUDAMED record Report an error
Computed tomographs (CT) - medical device software	Z11030692	myAblation Guide MDR_VT_IIb_ERLN_H_127_CTH_P10_Application Software2 refs syngo.CT Cardiac Planning syngo.CT PP_IIb_App_ERLN H 1273 refs	IIb MDR	EUDAMED record Report an error
Digital mammography systems	Z11030202	MAMMOMAT B.brilliant MDR_18_II b_ERLN H 127_Mammo_digital2 refs Mammomat Fusion MDD_18_IIB_ERLN H 127_Mammo_Digital93/42	IIb MDR, 93/42	EUDAMED record Report an error
General medicine diagnosis and monitoring instruments - medical device software	Z12040192	AI-Rad Companion Brain MR MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_MR-B2 refs AI-Rad Companion (Cardiovascular) MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-CV (no longer marketed) AI-Rad Companion (Musculoskeletal) MDR_VD_IIa_ERLN_H_127_SAMD_AIRC_CT-MSK (no longer marketed)	IIa MDR	EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field less than or equal to 2t	Z11050104	MAGNETOM Aera MDR_02_IIa_ERLN H 127_ACDV_Magnetom3 refs	IIa MDR	EUDAMED record Report an error
Computed tomographs (CT) - software accessories	Z11030682	syngo.CT ASPECTS syngo.CT PP_IIa_App_ERLN H 1273 refs	IIa MDR	EUDAMED record Report an error
Computed tomographs - 128 layers or more but less than 256 layers	Z11030606	NAEOTOM Alpha CT-Scanner_IIb_ERLN H 1273 refs	IIb MDR	EUDAMED record Report an error
Computed tomographs - 16 layers or more but less than 64 layers	Z11030603	NAEOTOM Alpha Combination CT-Scanner-COMBI_ERLN H 1273 refs	IIb MDR	EUDAMED record Report an error
Digital angiography systems - medical device software	Z11030192	MDR_01_IIb_FOR_ACDV_syngo Application Software (VEx)3 refs	IIb MDR	EUDAMED record Report an error
Digital angiography systems - software accessories	Z11030182	MDR_01_IIb_FOR_ACDV_syngo Application Software (VD30)	IIb MDR	EUDAMED record Report an error
Magnetic resonance (mr) systems - medical device software	Z11050192	Chondral Quant MDR_02_IIa_ERLN H 127_ACDV_SaMD3 refs	IIa MDR	EUDAMED record Report an error
Mammography systems - medical device software	Z11030292	MAMMOVISTA B.smart MDR_18_II b_ERLN H 127_WHSAMD2 refs	IIb MDR	EUDAMED record Report an error
Mobile radiographic units	Z11039016	MOBILETT Elara Max MDR_17_II b_ERLN H 127_Mobil_digital2 refs	IIb MDR	EUDAMED record Report an error

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