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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
Magnetic resonance imaging (MRI) instruments
Z1105
732 devices
Subcategories
2
Z110501
Magnetic resonance (mr) systems
506
devices
›
Z110590
Various magnetic resonance imaging (MRI) instruments
226
devices
›
Devices
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
Magnetic Resonance Imaging System
Shenzhen Basda Medical Apparatus Co., Ltd.
·
,
China
Class IIa
CE/MDD
Prodiva 1.5T CX
Philips Healthcare (Suzhou) Co., Ltd.
·
,
China
Class IIb
FDA 510(k)
K173507
Active
Cleared 15 Jun 2018
CE/MDR
1.5T HDxt Upgrade Kit
GE Medical Systems, LLC
·
,
United States
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Evolution Upgrade 1.5T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
·
,
United States
Class IIa
FDA 510(k)
×3
K253489
Active
Cleared 12 Dec 2025
CE/MDR
+1
authorizations
Ingenia Ambition X
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Marlin 1.5T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Magnetic Resonance Imaging System
Shenzhen Basda Medical Apparatus Co., Ltd.
·
,
China
Class IIa
CE/MDD
SIGNA Artist Evo
Open recall
Ge Healthcare(Tianjin) Company Limited
·
,
China
Class IIa
FDA 510(k)
K213603
Active
Cleared 11 Feb 2022
CE/MDR
+1
authorizations
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
NeuMR Rena
Neusoft Medical Systems Co., Ltd.
·
,
China
Class IIa
CE/MDR
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