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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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Magnetic resonance (mr) systems - medical device software
Magnetic resonance (mr) systems - medical device software
Z11050192
22 devices
Devices
PROView
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
MRI Image Analysis Software
Shanghai United Imaging Intelligence Co., Ltd.
·
,
CN
Class IIa
CE/MDR
88001297
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K233186
Active
Cleared 17 Apr 2024
FDA 510(k)
K253077
Active
Cleared 22 Apr 2026
+2
authorizations
88000844
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K192601
Active
Cleared 1 Jun 2020
FDA 510(k)
K172999
Active
Cleared 7 Nov 2018
+2
authorizations
RTgo
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
MR VesselIQ Xpress
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
MR VesselIQ Xpress
GE Medical Systems SCS
·
,
FR
Class IIa
FDA 510(k)
K122164
Active
Cleared 7 Sep 2012
CE/MDR
READY View
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
Digital Expert Access
GE Healthcare
·
,
US
Class IIa
CE/MDR
GUDID
on market
BreView
GE Medical Systems SCS
·
,
FR
Class IIa
FDA 510(k)
K233714
Active
Cleared 25 Jan 2024
CE/MDR
MR VesselIQ Xpress
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
MR VesselIQ Xpress
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
RTgo
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
READY View
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
READY View
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
MR Contour DL
GE Healthcare
·
,
US
Class IIa
FDA 510(k)
K242925
Active
Cleared 1 Apr 2025
CE/MDR
GenIQ
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
cNeuro cMRI
SyntheticMR AB
·
,
SE
Class IIa
CE/MDR
28620110677-01
Active
Valid to Sep 2027
PROView
GE Medical Systems SCS
·
,
FR
Class IIa
FDA 510(k)
K193306
Active
Cleared 17 Nov 2020
CE/MDR
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