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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
Devices
Magnifico Open
Esaote S.p.A.
·
,
IT
Class IIa
FDA 510(k)
K251901
Active
Cleared 5 Mar 2026
CE/MDR
+1
authorizations
AIRIS Vento
Fujifilm Corporation
·
,
JP
Class IIa
CE/MDR
MROpen Evo
ASG Superconductors S.p.A.
·
,
IT
Class IIa
FDA 510(k)
K193116
Active
Cleared 20 Dec 2019
CE/MDR
Magnetic Resonance Imaging System
Shenzhen Anke High-Tech Co., Ltd.
·
,
CN
Class IIa
CE/MDD
MROpen Evo
ASG Superconductors S.p.A.
·
,
IT
Class IIa
CE/MDR
AIRIS Vento
Fujifilm Corporation
·
,
JP
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
S-scan Premium
Esaote S.p.A.
·
,
IT
Class IIa
CE/MDD
AIRIS Vento
Fujifilm Corporation
·
,
JP
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
I-Genius
Esaote S.p.A.
·
,
IT
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
AIRIS Vento
Fujifilm Corporation
·
,
JP
Class IIa
CE/MDR
S-scan Open ReLife
Esaote S.p.A.
·
,
IT
Class IIa
CE/MDR
G-scan Brio Premium
Esaote S.p.A.
·
,
IT
Class IIa
CE/MDD
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Magnetic Resonance Imaging System
Shenzhen Basda Medical Apparatus Co., Ltd.
·
,
CN
Class IIa
CE/MDD
Magnetic Resonance Imaging System
Shenzhen Basda Medical Apparatus Co., Ltd.
·
,
CN
Class IIa
CE/MDD
AIRIS Vento
Fujifilm Corporation
·
,
JP
Class IIa
CE/MDR
03-4000-00
ASG Superconductors S.p.A.
·
,
IT
Class IIa
CE/MDR
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