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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
Devices
iDR603V-110
Yian Medical Technology (Haining) Co., Ltd.
·
,
CN
Class IIb
CE/MDR
US980
Ningbo Runyes Medical Instrument Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
FR
Class IIa
CE/MDR
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
FR
Class IIa
CE/MDR
Armonicus
Villa Sistemi Medicali S.P.A.
·
,
IT
Class IIb
CE/MDR
ArtPix DRF
CMT Medical Technologies, Ltd.
·
,
IL
Class IIb
CE/MDD
FDA 510(k)
K202235
Active
Cleared 3 Sep 2020
+2
authorizations
RAPIXX DR-System 4336M1F ES WiFi Set
PROTEC X-ray Systems GmbH
·
,
DE
Class IIb
CE/MDR
Six 650HD-E
CMT Medical Technologies, Ltd.
·
,
IL
Class IIa
CE/MDD
CE/MDR
Medical Diagnostic X-Ray Equipment
Zhuhai Perlead Medical Equipment Co., Ltd.
·
,
CN
Class IIb
CE/MDD
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
CN
Class IIb
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
FR
Class IIa
CE/MDR
PRIMAX International Primo-W
A.T.S. Applicazione Tecnologie Speciali s.r.l.
·
,
IT
Class IIb
FDA 510(k)
K211542
Active
Cleared 9 Jul 2021
CE/MDD
CareView 1800Cwe
Careray Digital Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
GUDID
on market
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K202350
Active
Cleared 6 Jan 2021
CE/MDR
+1
authorizations
Expd 4343P
Drtech Corp.
·
,
KR
Class IIa
FDA 510(k)
K232082
Active
Cleared 13 Feb 2024
CE/MDR
+1
authorizations
YosemiteView 3643W
Careray Digital Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
GUDID
on market
Lucerna RF-TILT
General Medical Italia LTD Swiss Branch
·
,
CH
Class IIb
CE/MDR
meX+ 1717LGW
BRS-Brieden Radiologische Systemlösungen GmbH
·
,
DE
Class IIb
CE/MDR
YosemiteView 4343W
Careray Digital Medical Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
GUDID
on market
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