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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 imaging (MRI) instruments
Z1105
732 devices
Subcategories
2
Z110501
Magnetic resonance (mr) systems
506
devices
›
Z110590
Various magnetic resonance imaging (MRI) instruments
226
devices
›
Devices
Magnetic Resonance Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
CE/MDR
Ingenia Elition S
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
NeuMR Universal
Neusoft Medical Systems Co., Ltd.
·
,
China
Class IIa
CE/MDR
SmartPath to dStream for XR and 3.0T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Ingenia Elition X
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Magnetic Resonance Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
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.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Upgrade to MR 7700
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Upgrade to MR 7700
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SIGNA Hero
GE Medical Systems, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
SmartPath to Ingenia Elition X
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Ingenia Elition S
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SmartPath to MR 7700
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SmartPath to Ingenia Elition X
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Ingenia Elition X
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Magnetic Resonance Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
K260113
Active
Cleared 22 May 2026
CE/MDR
SIGNA Pioneer
GE Medical Systems, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Ingenia Elition X
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SIGNA Architect
GE Medical Systems, LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
88000004
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
×2
K193176
Active
Cleared 5 May 2020
CE/MDD
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