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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
/
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
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
Upgrades dStream to R13
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Ingenia Ambition X
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Upgrades dStream to R12.3
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
DV GOC Upgrade Console
GE Medical Systems, LLC
·
,
United States
Class IIa
CE/MDR
Upgrades Achieva to R11
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Upgrades dStream to R5.7
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
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