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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 (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Evolution Upgrade 1.5T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
BlueSeal XE
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SIGNA Prime Elite
Open recall
Ge Healthcare(Tianjin) Company Limited
·
,
China
Class IIa
FDA 510(k)
K211980
Active
Cleared 16 Jan 2022
CE/MDR
+1
authorizations
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
MAGNETOM Flow.Ace S
Siemens Shenzhen Magnetic Resonance Ltd.
·
,
China
Class IIa
CE/MDR
Ingenia 1.5T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
SIGNA Sprint
Ge Healthcare(Tianjin) Company Limited
·
,
China
Class IIa
CE/MDR
GUDID
on market
neo315
Neoscan Solutions GmbH
·
,
Germany
Class IIa
FDA 510(k)
K231133
Active
Cleared 22 Jul 2024
CE/MDR
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Swoop Portable MR Imaging System
Hyperfine, Inc.
·
,
United States
Class IIa
FDA 510(k)
×5
K232760
Active
Cleared 6 Oct 2023
CE/MDR
+1
authorizations
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
Upgrade Marlin to R5.7
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
SIGNA Prime
Ge Healthcare(Tianjin) Company Limited
·
,
China
Class IIa
CE/MDR
GUDID
on market
Evolution Upgrade 1.5T
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIb
CE/MDR
2243595CE01
Active
Valid to May 2030
GUDID
on market
Magnetic Resonance (MR) Systems
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
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
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