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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
Digital bioimaging management instruments
Z1106
1,060 devices
Subcategories
4
Z110601
Laser imaging scanner
98
devices
Z110602
Digital computed radiography (cr) systems
98
devices
›
Z110603
Picture archiving and communication systems
248
devices
Z110690
Various digital bioimaging management instruments
616
devices
›
Devices
IntelePACS
Open recall
Intelerad Medical Systems Incorporated
·
,
Canada
Class IIa
FDA 510(k)
×2
K192176
Active
Cleared 2 Apr 2020
CE/MDR
Universal Viewer v8
Open recall
GE Healthcare
·
,
United States
Class IIa
FDA 510(k)
K211312
Active
Cleared 21 May 2021
CE/MDD
+1
authorizations
Telemis
Telemis GmbH
·
,
Germany
Class IIb
CE/MDD
InteleShare
Intelerad Holdings USA Ltd
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Vitrea Read
Canon Medical Informatics A/S
·
,
Denmark
Class IIa
CE/MDR
28620128868
Expiring
Valid to Apr 2027
GUDID
on market
GXD5 PACS version 4
Enovacom
·
,
France
Class I
CE/MDR
Merge Universal Viewer
Merge Healthcare Incorporated
·
,
United States
Class IIa
CE/MDD
GUDID
on market
iQ-4VIEW 2.4
IMAGE INFORMATION SYSTEMS EUROPE GmbH
·
,
Germany
Class IIb
CE/MDR
Centricity Universal Viewer Zero Footprint Client v6.0
Open recall
GE Healthcare
·
,
United States
Class IIa
FDA 510(k)
K131977
Active
Cleared 17 Sep 2013
CE/MDD
+1
authorizations
Mirada XD
Mirada Medical, Ltd.
·
,
United Kingdom
Class IIa
CE/MDR
GUDID
on market
JiveX
VISUS Health IT GmbH
·
,
Germany
Class IIa
CE/MDR
Vitrea Read
Canon Medical Informatics A/S
·
,
Denmark
Class IIa
CE/MDR
28620128868
Expiring
Valid to Apr 2027
GUDID
on market
Chili Pacs
NEXUS / CHILI GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
iQ-VIEW 4.0
IMAGE INFORMATION SYSTEMS EUROPE GmbH
·
,
Germany
Class IIb
CE/MDR
Centricity Universal Viewer 6.0
Open recall
GE Healthcare
·
,
United States
Class IIa
FDA 510(k)
×2
K182419
Active
Cleared 14 Dec 2018
CE/MDD
+1
authorizations
synedra View Professional 24 Herakles
synedra information technologies GmbH
·
,
Austria
Class IIb
CE/MDR
170780826
Withdrawn
Valid to Dec 2026
CE/MDR
1000326253
Expiring
Valid to Dec 2026
Visage 7
Visage Imaging, Inc.
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
synedra AIM 25 Rhea
synedra information technologies GmbH
·
,
Austria
Class IIb
CE/MDR
1000326253
Expiring
Valid to Dec 2026
CE/MDR
170780826
Withdrawn
Valid to Dec 2026
Marie Pacs
OR-CZ spol. s r.o.
·
,
Czechia
Class IIb
CE/MDR
2023-MDR/QS-007/A
Active
Valid to May 2028
Simplicit90Y
Mirada Medical, Ltd.
·
,
United Kingdom
Class IIa
CE/MDR
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