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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
EXINI Bone
Exini Diagnostics Ab
·
,
Sweden
Class IIa
FDA 510(k)
K122205
Active
Cleared 15 Aug 2012
CE/MDR
+1
authorizations
Universal Viewer 8.1
GE Healthcare
·
,
United States
Class IIa
CE/MDR
GUDID
on market
EMR Manager
Vepro AG
·
,
Germany
Class IIa
CE/MDR
synedra AIM 23 Selene
synedra information technologies GmbH
·
,
Austria
Class IIb
CE/MDR
170780826
Withdrawn
Valid to Dec 2026
CE/MDR
1000326253
Expiring
Valid to Dec 2026
digipaX 2.2
digipaX GmbH
·
,
Germany
Class IIb
CE/MDR
XR PACS imagepro 8
D.A.T.A. Corporation
·
,
Austria
Class IIb
CE/MDR
1000208388
Active
Valid to Oct 2030
Vitrea Read
Canon Medical Informatics A/S
·
,
Denmark
Class IIa
CE/MDR
28620128868
Expiring
Valid to Apr 2027
GUDID
on market
X-Store Web
M.I. Medical S.r.l.
·
,
Italy
Class IIb
CE/MDD
Vizo+
Softmed Sp. z o.o.
·
,
Poland
Class IIa
CE/MDR
Dentally Vision
Henry Schein One, LLC
·
,
United States
Class I
CE/MDD
Cercare Medical Neurosuite
Cercare Medical A/S
·
,
Denmark
Class IIa
FDA 510(k)
K230016
Active
Cleared 14 Jul 2023
CE/MDR
+1
authorizations
Sicat Function V2.0.40
SICAT GmbH & Co. KG
·
,
Germany
Class IIa
FDA 510(k)
K133320
Active
Cleared 25 Feb 2014
CE/MDR
+1
authorizations
MammoView
medigration GmbH
·
,
Germany
Class IIb
CE/MDD
Centricity PACS - RA1000 v7.0
GE Healthcare
·
,
United States
Class IIa
CE/MDD
GUDID
on market
DeepUnity Diagnost
DH Healthcare GmbH
·
,
Germany
Class IIa
CE/MDR
Onepix
Unident AB
·
,
Sweden
Class IIa
CE/MDR
28620145488
Active
Valid to Dec 2027
Enterprise Imaging Desktops
Agfa HealthCare NV
·
,
Belgium
Class IIa
CE/MDR
28620117074
Expired
Valid to Aug 2026
GUDID
on market
NVFundus
Ural Telekomüni̇kasyon San. Ti̇c. A.ş
·
,
Türkiye
Class I
CE/MDR
Centricity Radiology RA600 v7.0 +2 more models
Open recall
GE Healthcare
·
,
United States
Class IIa
FDA 510(k)
K042525
Active
Cleared 1 Oct 2004
CE/MDD
HubVue Imaging Workflow System
ACIST Medical Systems, Inc.
·
,
United States
Class I
CE/MDR
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