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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 4t
Closed magnet MRI scanners with magnetic field greater than 4t
Z11050106
2 devices
Devices
Signa 7.0T
Open recall
Ge Medical Systems, Inc.
·
,
US
Class IIa
FDA 510(k)
K211118
Active
Cleared 13 May 2021
FDA 510(k)
K201615
Active
Cleared 15 Oct 2020
+2
authorizations
Magnetic Resonance Imaging System
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K250246
Active
Cleared 5 Aug 2025
FDA 510(k)
K233673
Active
Cleared 26 Apr 2024
+2
authorizations
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