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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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Closed magnet MRI scanners with magnetic field greater than 2t and less than or equal to 4t
Closed magnet MRI scanners with magnetic field greater than 2t and less than or equal to 4t
Z11050105
42 devices
Devices
SmartPath to MR 7700
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Ingenia 3.0T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SmartPath to dStream for 3.0T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Evolution Upgrade 3.0T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
88000196
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K243122
Active
Cleared 21 May 2025
FDA 510(k)
K240540
Active
Cleared 22 Mar 2024
+4
authorizations
SIGNA Premier
Open recall
GE Medical Systems, LLC
·
,
US
Class IIa
FDA 510(k)
K183231
Active
Cleared 18 Jan 2019
FDA 510(k)
K171128
Active
Cleared 14 Jul 2017
+2
authorizations
Evolution Upgrade 3.0T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Ingenia Elition 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 XR and 3.0T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
SmartPath to dStream for XR and 3.0T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Evolution Upgrade 3.0T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Mr 7700
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Upgrade dStream
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Magnetic Resonance Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Ingenia Elition S
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
NeuMR Universal
Neusoft Medical Systems Co., Ltd.
·
,
CN
Class IIa
CE/MDR
SmartPath to dStream for XR and 3.0T
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Ingenia Elition X
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Magnetic Resonance Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K243547
Active
Cleared 17 Jul 2025
CE/MDR
+1
authorizations
SmartPath to Ingenia Elition X
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
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