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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 (mr) systems
/
Closed magnet MRI scanners with magnetic field less than or equal to 2t
Closed magnet MRI scanners with magnetic field less than or equal to 2t
Z11050104
90 devices
Devices
1.5T HDxt Upgrade Kit
Ge Medical Systems, Inc.
·
,
US
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Evolution Upgrade 1.5T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
·
,
US
Class IIa
FDA 510(k)
K253489
Active
Cleared 12 Dec 2025
FDA 510(k)
K240944
Active
Cleared 16 Jul 2024
+3
authorizations
Ingenia Ambition X
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Marlin 1.5T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
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
SIGNA Artist Evo
Open recall
Ge Healthcare(Tianjin) Company Limited
·
,
CN
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.
·
,
CN
Class IIa
CE/MDR
NeuMR Rena
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Evolution Upgrade 1.5T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
BlueSeal XE
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
SIGNA Prime Elite
Open recall
Ge Healthcare(Tianjin) Company Limited
·
,
CN
Class IIa
FDA 510(k)
K211980
Active
Cleared 16 Jan 2022
CE/MDR
+1
authorizations
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
MAGNETOM Flow.Ace S
Siemens Shenzhen Magnetic Resonance Ltd.
·
,
CN
Class IIa
CE/MDR
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