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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
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Ingenia Ambition S
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SmartPath to dStream for 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 (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
EchoStar 1.5T
Alltech Medical Systems, LLC.
·
,
CN
Class IIa
CE/MDD
Ingenia Ambition S
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SmartPath to dStream for 1.5T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
SIGNA Voyager
Open recall
Ge Healthcare(Tianjin) Company Limited
·
,
CN
Class IIa
FDA 510(k)
K161567
Active
Cleared 1 Sep 2016
CE/MDR
+1
authorizations
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
MAGNETOM Flow.Plus
Siemens Shenzhen Magnetic Resonance Ltd.
·
,
CN
Class IIa
CE/MDR
NeuMR Rena C
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
Mr 5300
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Ingenia 1.5T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
BlueSeal SE
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
FDA 510(k)
K253648
Active
Cleared 23 Feb 2026
SIGNA Explorer
Ge Healthcare(Tianjin) Company Limited
·
,
CN
Class IIa
CE/MDR
GUDID
on market
88000653
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
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