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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
GC85A
Samsung Electronics Co., Ltd
·
,
South Korea
Class IIb
FDA 510(k)
×4
K150165
Active
Cleared 2 Apr 2015
CE/MDR
+1
authorizations
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Definium Tempo
GE Hualun Medical Systems Co., Ltd
·
,
China
Class IIb
CE/MDR
GUDID
on market
DIGITAL RADIOGRAPHY CXDI-Pro
Canon Inc.
·
,
Japan
Class IIa
FDA 510(k)
×3
K222855
Active
Cleared 17 Oct 2022
CE/MDR
+1
authorizations
RAPIXX DR-System 4336M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
iDR605T-110
Yian Medical Technology (Haining) Co., Ltd.
·
,
China
Class IIb
CE/MDR
meX+ 1417LGW
BRS-Brieden Radiologische Systemlösungen GmbH
·
,
Germany
Class IIb
CE/MDR
Evs 3643W
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
RAPIXX DR-System 4336M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
RAPIXX DR-System 4336M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Vision V
Visaris
·
,
Serbia
Class IIb
CE/MDD
GUDID
on market
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
RAPIXX DR-System 12043M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Vision C
Visaris
·
,
Serbia
Class IIb
CE/MDD
GUDID
on market
Flat Panel Digital X-ray Detector
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Digital Radiography System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIb
CE/MDR
RAPIXX DR-System 4343M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Digital Medical X-ray Radiographic System
Shenzhen Angell Technology Co., Ltd
·
,
China
Class IIb
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
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