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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
Armonicus
Villa Sistemi Medicali S.P.A.
·
,
Italy
Class IIb
CE/MDR
CareView 3600RF
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Medical Diagnostic X-Ray Equipment
Zhuhai Perlead Medical Equipment Co., Ltd.
·
,
China
Class IIb
CE/MDD
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Expd 86PG
Drtech Corp.
·
,
South Korea
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
iDR605T-220
Yian Medical Technology (Haining) Co., Ltd.
·
,
China
Class IIb
CE/MDR
DuraDiagnost F30
Philips Healthcare (Suzhou) Co., Ltd.
·
,
China
Class IIb
CE/MDR
Expd 86P
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
RAPIXX DR-System 4336M2F ES WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
RAPIXX DR-System 4336M1i X WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
RSM 2430C Choice
Drtech Corp.
·
,
South Korea
Class IIa
FDA 510(k)
K170930
Active
Cleared 27 Apr 2017
CE/MDR
Evs 3643A
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Medical X-ray Radiography Unit
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDD
Xera
XERA Medical Systems and Technology Ltd.
·
,
Türkiye
Class IIb
CE/MDD
GUDID
on market
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
China
Class IIb
CE/MDR
GUDID
on market
Direct Digital Radiology System
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
iDR603T-220
Yian Medical Technology (Haining) Co., Ltd.
·
,
China
Class IIb
CE/MDR
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