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Medical equipment and related accessories, software and consumables
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Bioimaging and radiotherapy instruments
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Digital bioimaging management instruments
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Picture archiving and communication systems
Picture archiving and communication systems
Z110603
248 devices
Devices
Vitrea Read
Canon Medical Informatics A/S
·
,
DK
Class IIa
CE/MDR
28620128868
Active
Valid to Apr 2027
GUDID
on market
Centricity PACS - RA1000 v6.0
Open recall
GE Healthcare
·
,
US
Class IIa
FDA 510(k)
K110875
Active
Cleared 5 May 2011
CE/MDD
+1
authorizations
Synopsys Simpleware™ ScanIP P-2019.09
Synopsys (Northern Europe) Ltd
·
,
GB
Class IIa
CE/MDD
GUDID
on market
iQ-VIEW 4.1
IMAGE INFORMATION SYSTEMS EUROPE GmbH
·
,
DE
Class IIb
CE/MDR
Merge Universal Viewer
Merge Healthcare Incorporated
·
,
US
Class IIa
CE/MDD
GUDID
on market
Vitrea Read
Canon Medical Informatics A/S
·
,
DK
Class IIa
CE/MDR
28620128868
Active
Valid to Apr 2027
GUDID
on market
Velocity
Varian Medical Systems, Inc
·
,
US
Class IIb
CE/MDR
IntelliSpace Cardiovascular 9
Philips Medical Systems Nederland B.V.
·
,
NL
Class IIa
CE/MDR
2243163CE01
Active
Valid to Jul 2030
Vitrea
Canon Medical Informatics, Inc.
·
,
US
Class IIa
CE/MDR
GUDID
on market
ViewPoint 6
GE Healthcare GmbH
·
,
DE
Class IIa
CE/MDR
GUDID
on market
Tomtec-Arena
Philips Ultrasound LLC
·
,
US
Class IIa
CE/MDR
GUDID
on market
Amis*pacs Flexserver G2
ICZ.HEA a.s.
·
,
CZ
Class IIb
CE/MDD
ENDOANGEL Pancreas Image Processing Software in EUS
Wuhan ENDOANGEL Medical Technology Co., LTD.
·
,
CN
Class I
CE/MDR
Disior Bonelogic 1.0
Disior Oy
·
,
FI
Class IIb
CE/MDD
iQ-ROUTER 5.1
IMAGE INFORMATION SYSTEMS EUROPE GmbH
·
,
DE
Class IIb
CE/MDR
Capillary Function
Cercare Medical A/S
·
,
DK
Class IIa
CE/MDR
GUDID
on market
iQ-WEB 7.2.9
IMAGE INFORMATION SYSTEMS EUROPE GmbH
·
,
DE
Class IIb
CE/MDR
IntelePACS
Open recall
Intelerad Medical Systems Incorporated
·
,
CA
Class IIa
FDA 510(k)
K192176
Active
Cleared 2 Apr 2020
FDA 510(k)
K150707
Active
Cleared 27 May 2015
+1
authorizations
Universal Viewer v8
Open recall
GE Healthcare
·
,
US
Class IIa
FDA 510(k)
K211312
Active
Cleared 21 May 2021
CE/MDD
+1
authorizations
Telemis
Telemis GmbH
·
,
DE
Class IIb
CE/MDD
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