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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
GF85-3P
Samsung Electronics Co., Ltd
·
,
South Korea
Class IIb
CE/MDR
GUDID
on market
DIGITAL RADIOGRAPHY CXDI-710C Wireless
Canon Inc.
·
,
Japan
Class IIa
FDA 510(k)
K170332
Active
Cleared 1 Mar 2017
CE/MDR
+1
authorizations
Browiner
Shenzhen Browiner Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
RAPIXX DR-System 4336M1F ES WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Browiner
Shenzhen Browiner Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Browiner
Shenzhen Browiner Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Dr 400
Agfa NV
·
,
Belgium
Class IIb
CE/MDR
28620125060
Expiring
Valid to May 2027
GUDID
on market
Dr 400
Agfa NV
·
,
Belgium
Class IIb
CE/MDR
28620125060
Expiring
Valid to May 2027
GUDID
on market
Direct Digital Radiology System
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
Definium Tempo Select
GE Hualun Medical Systems 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
iDR605V-110
Yian Medical Technology (Haining) Co., Ltd.
·
,
China
Class IIb
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Dr 600
Agfa NV
·
,
Belgium
Class IIb
CE/MDR
28620125060
Expiring
Valid to May 2027
GUDID
on market
Flat Panel Digital X-ray Detector
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
SIX650HD-E-Gs
CMT Medical Technologies, Ltd.
·
,
Israel
Class IIa
CE/MDD
CE/MDR
Evs 4343WP
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
CareView 750Cw
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
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