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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Magnetic resonance imaging (MRI) instruments
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Magnetic resonance (mr) systems
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Open magnet MRI scanners with magnetic field intensity less than or equal to 0.5t
Open magnet MRI scanners with magnetic field intensity less than or equal to 0.5t
Z11050102
52 devices
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
MR Open EVO
ASG Superconductors S.p.A.
·
,
Italy
Class IIa
CE/MDD
S-scan Open
Esaote S.p.A.
·
,
Italy
Class IIa
FDA 510(k)
K260746
Active
Cleared 27 Mar 2026
CE/MDR
+1
authorizations
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
G-scan Open
Esaote S.p.A.
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
Magnetic Resonance Imaging System
Kuanteng (Liaoning) Medical Devices Co., Ltd.
·
,
China
Class IIa
CE/MDD
CE/MDR
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
MROpen Evo
ASG Superconductors S.p.A.
·
,
Italy
Class IIa
FDA 510(k)
K242258
Active
Cleared 26 Nov 2024
CE/MDR
Magnetic Resonance Imaging System
Shenzhen Basda Medical Apparatus Co., Ltd.
·
,
China
Class IIa
CE/MDD
AIRIS Vento
Fujifilm Corporation
·
,
Japan
Class IIa
CE/MDR
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