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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
RAPIXX DR-System 4343M1i WiFi Set
PROTEC X-ray Systems GmbH
·
,
Germany
Class IIb
CE/MDR
Lanmage
Shenzhen Lanmage Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
XPERT42
Kub Technologies Inc
·
,
United States
Class I
CE/MDR
Rsm 2430C
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Expd 3643P
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
FDA 510(k)
K202353
Active
Cleared 23 Dec 2020
CE/MDR
+1
authorizations
CareView 1500P
Careray Digital Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Definium Pace Select ET
Open recall
GE Hualun Medical Systems Co., Ltd
·
,
China
Class IIb
FDA 510(k)
×2
K231892
Active
Cleared 12 Sep 2023
CE/MDR
+1
authorizations
US990
Ningbo Runyes Medical Instrument Co., Ltd.
·
,
China
Class IIa
CE/MDR
Expd 129PG
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
SIX650HD-E-Gp
CMT Medical Technologies, Ltd.
·
,
Israel
Class IIa
CE/MDD
CE/MDR
Pixium Dynamic
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
Browiner
Shenzhen Browiner Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
DR750
Ningbo Youjoy Dental Equipment Co., Ltd.
·
,
China
Class IIa
CE/MDR
Flat Panel Digital X-ray Detector
Drtech Corp.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Browiner
Shenzhen Browiner Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Pixium Static
Thales Avs France SAS
·
,
France
Class IIa
CE/MDR
iDR603T-110
Yian Medical Technology (Haining) Co., Ltd.
·
,
China
Class IIb
CE/MDR
Flat Panel Digital X-ray Detector
Drtech Corp.
·
,
South Korea
Class IIa
FDA 510(k)
K243443
Active
Cleared 19 Mar 2025
CE/MDR
+1
authorizations
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