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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
ArtPix Mobile EZ2GO
CMT Medical Technologies, Ltd.
·
,
Israel
Class IIb
CE/MDD
FDA 510(k)
K162224
Active
Cleared 22 Sep 2016
+2
authorizations
Sixteen-Gp
CMT Medical Technologies, Ltd.
·
,
Israel
Class IIa
CE/MDD
CE/MDR
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
China
Class IIb
CE/MDR
GUDID
on market
DR 100s
Agfa NV
·
,
Belgium
Class IIb
CE/MDR
28620125060
Expiring
Valid to May 2027
FDA 510(k)
K191884
Active
Cleared 9 Aug 2019
+1
authorizations
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
RAPIXX DR-System 4336M2F ES CC Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
DR730
Ningbo Youjoy Dental Equipment Co., Ltd.
·
,
China
Class IIa
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
RAPIXX DR-System 4343M1F ES WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
RAPIXX DR-System 4343M1i X CC Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
2316 Sixteen-Cs
CMT Medical Technologies, Ltd.
·
,
Israel
Class IIa
CE/MDD
CE/MDR
XPERT40
Kub Technologies Inc
·
,
United States
Class I
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Direct Digital Radiology System
Beijing Wandong Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
XPERT20
Kub Technologies Inc
·
,
United States
Class I
CE/MDR
Sixteen-Cs
CMT Medical Technologies, Ltd.
·
,
Israel
Class IIa
CE/MDD
CE/MDR
XPERT84
Kub Technologies Inc
·
,
United States
Class I
CE/MDR
RAPIXX DR-System 12043M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
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