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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
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
DIGITAL RADIOGRAPHY CXDI-Elite
Canon Inc.
·
,
Japan
Class IIa
FDA 510(k)
×3
K213780
Active
Cleared 24 Jan 2022
CE/MDR
+1
authorizations
CareView 240RF
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Evs 4343W
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
CareView 1800RF
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Digital Radiography System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIb
CE/MDR
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
China
Class IIb
CE/MDR
GUDID
on market
Medical X-ray Radiography Unit
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDD
DIGITAL RADIOGRAPHY CXDI-810C Wireless
Canon Inc.
·
,
Japan
Class IIa
CE/MDR
GUDID
on market
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
China
Class IIb
CE/MDR
GUDID
on market
Flat Panel Digital X-ray Detector
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Flat Panel Detector Af-B1
Canon Inc.
·
,
Japan
Class I
CE/MDR
Definium Pace Select
GE Hualun Medical Systems Co., Ltd
·
,
China
Class IIb
CE/MDR
GUDID
on market
Lucerna U-ARM
General Medical Italia LTD Swiss Branch
·
,
Switzerland
Class IIb
CE/MDR
RAPIXX DR-System 4343M2F ES CC Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
RAPIXX DR-System 4343M2F ES WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
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