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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Diagnostic and interventional radiology instruments
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Direct digital radiology (dr) systems
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Multifunctional systems for direct digital radiology
Multifunctional systems for direct digital radiology
Z11031101
352 devices
RAPIXX DR-System 4343M1i X WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Swissrad Sb-4
MDTS medtechsolutions AG
·
,
Germany
Class IIb
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Digital X-Ray Radiography System
Kuanteng (Liaoning) Medical Devices Co., Ltd.
·
,
China
Class IIb
CE/MDD
DIGITAL RADIOGRAPHY CXDI-402C Wireless
Canon Inc.
·
,
Japan
Class IIa
CE/MDR
GUDID
on market
Armonicus
Villa Sistemi Medicali S.P.A.
·
,
Italy
Class IIb
CE/MDR
RAPIXX DR-System 4343M1i X CC Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
EverestView 4343X
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
5463900PCM
GE Hualun Medical Systems Co., Ltd
·
,
China
Class IIb
CE/MDD
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
RAPIXX DR-System 4343M1i X WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
YSIO X.pree VA20-SW-Update
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
CareView 1500Cwe
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Flat Panel Detector Ar-C4343W
Canon Inc.
·
,
Japan
Class I
CE/MDR
Valory
Agfa NV
·
,
Belgium
Class IIb
CE/MDR
28620125060
Expiring
Valid to May 2027
FDA 510(k)
K213469
Active
Cleared 18 Nov 2021
+1
authorizations
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
CareView 750L
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Digital X-Ray Radiography System
Kuanteng (Liaoning) Medical Devices Co., Ltd.
·
,
China
Class IIb
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
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