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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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Digital angiography systems
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Digital angiography systems - medical device software
Digital angiography systems - medical device software
Z11030192
29 devices
Devices
TrackVision 2
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
AngioViz
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
Volume Viewer Innova
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
uWS-Angio Software
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K243632
Active
Cleared 12 May 2025
FDA 510(k)
K250040
Active
Cleared 12 Sep 2025
+2
authorizations
FlightPlan for Embolization
GE Medical Systems SCS
·
,
FR
Class IIa
FDA 510(k)
K193261
Active
Cleared 24 Jan 2020
FDA 510(k)
K223490
Active
Cleared 21 Mar 2023
+1
authorizations
EVARVision
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
Volume Viewer Innova
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
Volume Viewer Innova
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
Vision 2
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
FlightPlan for Embolization
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
FlightPlan for Embolization
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
Cardiac X-ray Analysis
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
FlightPlan for Embolization
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
Volume Viewer Innova
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
FlightPlan for Embolization
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
HeartVision 2
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
uWS-Angio Pro Software
Shanghai United Imaging Healthcare Co., Ltd.
·
,
CN
Class IIa
FDA 510(k)
K250045
Active
Cleared 24 Sep 2025
CE/MDR
EVARVision
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
Advantage Paste
GE Medical Systems SCS
·
,
FR
Class IIa
CE/MDR
TrackVision 2
GE Medical Systems SCS
·
,
FR
Class IIb
CE/MDR
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