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Neusoft Digital Medical Systems Co., Ltd.

China·CN-MF-000011819

Last updated May 23, 2026

Information

Country: China
Address: 177-1, Chuangxin Road, Hunnan District, Shenyang, China
Website: neusoftmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Zhiqiang Wang
EUDAMED SRN: CN-MF-000011819
FDA FEI Number: —
DUNS Number: —

Catalogue (65)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
NeuViz Prime Max+	none	EUDAMED	Class IIb	Active
NeuViz 64 Multi-slice CT Scanner System	NeuViz 64i	FDA UDI	Class II	Active
NeuViz 128 Multi-slice CT Scanner System	NeuViz 128	FDA UDI	Class II	Active
NeuViz 64 Multi-slice CT Scanner System	NeuViz 64e	FDA UDI	Class II	Active
NeuSight PET/CT Scanner System	NeuSight PET/CT 16	FDA UDI	Class II	Unknown
NeuSight PET/CT Scanner System	NeuSight PET/CT 64	FDA UDI	Class II	Unknown
NeuAngio 30C	none	EUDAMED	Class IIb	Active
NeuViz ACE	none	EUDAMED	Class IIb	Active
NeuMR Universal	none	EUDAMED	Class IIa	Active
NeuViz ACE 32e	none	EUDAMED	Class IIb	Active
Ct-C3000 Spiral Ct Scanner System	K020913	FDA 510(k)	Class II	Active
Flying Diagnostic Ultrasound System	K083877	FDA 510(k)	Class II	Active
Neuviz Dual Multi-Slice Ct Scanner System	K062451	FDA 510(k)	Class II	Active
Modification To Superopen 0.23t, Model Nam-P023a	K062860	FDA 510(k)	Class II	Active
Clearview	K133373	FDA 510(k)	Class II	Active
NeuViz 128 Multi-slice CT Scanner System	K151383	FDA 510(k)	Class II	Active
Superopen 0.35t, Model Nsm-P035	K030918	FDA 510(k)	Class II	Active
Modification To Superopen 0.35t, Model Nsm-P035	K061132	FDA 510(k)	Class II	Active
Neucoloncare	K110077	FDA 510(k)	Class II	Active
Neusoft Spiral Ct Scanner System, Model Neuviz Version 2.0	K080540	FDA 510(k)	Class II	Active
NeuViz 16 Essence Multi-slice CT Scanner System	K171198	FDA 510(k)	Class II	Active
Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System	K151403	FDA 510(k)	Class II	Active
Modification To Neuviz Dual Multi-Slice Ct Scanner System	K071308	FDA 510(k)	Class II	Active
Beyondimage Workstation	K092235	FDA 510(k)	Class II	Active
Modification To Superopen 0.23t Mri System, Model Nam-P023a	K082485	FDA 510(k)	Class II	Active
Superstar 0.35t Mri System	K071154	FDA 510(k)	Class II	Active
Neuviz 16 Multi-Slice Ct Scanner System	K090173	FDA 510(k)	Class II	Active
Nsm-S15 System	K092237	FDA 510(k)	Class II	Active
Urocare	K090552	FDA 510(k)	Class II	Active
NeuViz Prime Multi-slice CT Scanner System	K171201	FDA 510(k)	Class II	Active
Neuviz 16 Multi-Slice Ct Scanner System	K092742	FDA 510(k)	Class II	Active
NeuViz 128 Multi-Slice CT Scanner System	K230220	FDA 510(k)	Class II	Active
Neuviz 64 Multi-Slice Ct Scanner System	K121792	FDA 510(k)FDA UDI	Class II	Active
Beyondimage Workstation	K102435	FDA 510(k)	Class II	Active
Ct-C3000dual And Ct-C2800dual Family Of Dual-Slice Ct Scanner Systems	K041542	FDA 510(k)	Class II	Active
Neuviz Spiral Ct Scanner System	K072841	FDA 510(k)	Class II	Active
Superopen 0.23t, Model Nam-P023a	K033315	FDA 510(k)	Class II	Active
NeuVision 550M Plus	none	EUDAMED	Class IIb	Active
NeuCare Mammo DR HD	none	EUDAMED	Class IIb	Active
NeuViz Epoch	none	EUDAMED	Class IIb	Active
NeuAngio 43CS	none	EUDAMED	Class IIb	Active
NeuViz ACE 128	none	EUDAMED	Class IIb	Active
NeuAngio 33F	none	EUDAMED	Class IIb	Active
NeuVision 460	none	EUDAMED	Class IIb	Active
NeuAngio 43C	none	EUDAMED	Class IIb	Active
NeuAngio 30F Flex	none	EUDAMED	Class IIb	Active
NeuViz ACE 64e	none	EUDAMED	Class IIb	Active
NeuAngio 33CS	none	EUDAMED	Class IIb	Active
NeuViz 64 In	none	EUDAMEDFDA UDI	Class IIb	Active
NeuAngio 33C	none	EUDAMED	Class IIb	Active

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