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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
/
Multifunctional systems for direct digital radiology
Multifunctional systems for direct digital radiology
Z11031101
352 devices
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Flat Panel Digital X-ray Detector
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
RAPIXX DR-System 4343M1i X WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
NeuVision 460
Neusoft Medical Systems Co., Ltd.
·
,
China
Class IIb
CE/MDD
Genève 40 M
General Medical Italia LTD Swiss Branch
·
,
Switzerland
Class IIb
CE/MDR
CareView 1800Le
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
DIGITAL RADIOGRAPHY CXDI-410C Wireless
Canon Inc.
·
,
Japan
Class IIa
FDA 510(k)
K171270
Active
Cleared 17 Nov 2017
CE/MDR
+1
authorizations
Evs 3643WP
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Xera
XERA Medical Systems and Technology Ltd.
·
,
Türkiye
Class IIb
CE/MDD
GUDID
on market
RAPIXX DR-System 4336M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
XPERT80L
Kub Technologies Inc
·
,
United States
Class I
CE/MDR
RAPIXX DR-System 4343M1i X WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Lanmage
Shenzhen Lanmage Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
Definium Tempo Pro
GE Hualun Medical Systems Co., Ltd
·
,
China
Class IIb
CE/MDR
GUDID
on market
Dr 400
Agfa NV
·
,
Belgium
Class IIb
CE/MDR
28620125060
Expiring
Valid to May 2027
GUDID
on market
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Digital Radiographic X-ray system
Dk Medical Systems Co., Ltd.
·
,
South Korea
Class IIb
CE/MDD
Expd 3030P
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
RAPIXX DR-System 4343M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
RAPIXX DR-System 4343M1F ES CC Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
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