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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
/
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
Ingenia 1.5T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SIGNA Sprint
Ge Healthcare(Tianjin) Company Limited
·
,
CN
Class IIa
CE/MDR
neo315
Neoscan Solutions GmbH
·
,
DE
Class IIa
FDA 510(k)
K231133
Active
Cleared 22 Jul 2024
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Swoop Portable MR Imaging System
Hyperfine, Inc.
·
,
US
Class IIa
FDA 510(k)
K232760
Active
Cleared 6 Oct 2023
FDA 510(k)
K230208
Active
Cleared 22 Feb 2023
+4
authorizations
Magnetic Resonance Imaging System
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
Upgrade Marlin to R5.7
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
SIGNA Prime
Ge Healthcare(Tianjin) Company Limited
·
,
CN
Class IIa
CE/MDR
GUDID
on market
Evolution Upgrade 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
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
SIGNA Creator
Ge Healthcare(Tianjin) Company Limited
·
,
CN
Class IIa
CE/MDR
GUDID
on market
Ingenia Ambition S
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
NeuMR 1.5T
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIa
CE/MDR
SIGNA Victor
Open recall
Ge Healthcare(Tianjin) Company Limited
·
,
CN
Class IIa
FDA 510(k)
K223439
Active
Cleared 13 Feb 2023
CE/MDR
+1
authorizations
SIGNA Champion
Ge Healthcare(Tianjin) Company Limited
·
,
CN
Class IIa
FDA 510(k)
K233728
Active
Cleared 19 Jan 2024
CE/MDR
+1
authorizations
Mr 5300
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
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