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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
Mr 5300
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Ingenia 1.5T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
BlueSeal SE
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
FDA 510(k)
K253648
Active
Cleared 23 Feb 2026
+1
authorizations
SIGNA Explorer
Ge Healthcare(Tianjin) Company Limited
·
,
China
Class IIa
CE/MDR
GUDID
on market
Magnetic Resonance Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Magnetic Resonance Imaging System
Shenzhen Anke High-Tech Co., Ltd.
·
,
China
Class IIa
CE/MDR
CE/MDD
BlueSeal QE
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SIGNA Artist
Open recall
Ge Healthcare(Tianjin) Company Limited
·
,
China
Class IIa
FDA 510(k)
K202238
Active
Cleared 4 Sep 2020
CE/MDR
+1
authorizations
MAGNETOM Flow.Apex
Siemens Shenzhen Magnetic Resonance Ltd.
·
,
China
Class IIa
CE/MDR
88000654
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
×3
K243397
Active
Cleared 16 Jul 2025
CE/MDR
+1
authorizations
SIGNA Artist
Ge Healthcare(Tianjin) Company Limited
·
,
China
Class IIa
CE/MDR
GUDID
on market
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Upgrades Achieva/Intera to R5.7
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Upgrades dStream to R12
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Mr 7700
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Mr 5300
Open recall
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
FDA 510(k)
K212673
Active
Cleared 19 Nov 2021
+1
authorizations
Upgrades dStream to R11
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
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