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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
Centricity Universal Viewer 7.0
GE Healthcare
·
,
United States
Class IIa
CE/MDD
GUDID
on market
ScopyDoc
Medsynaptic Pvt Ltd
·
,
India
Class I
CE/MDR
Capillary Function
Cercare Medical A/S
·
,
Denmark
Class IIa
CE/MDR
GUDID
on market
Gempacs
DRGEM Corporation
·
,
South Korea
Class I
CE/MDR
GUDID
on market
ImageBroker
medigration GmbH
·
,
Germany
Class I
CE/MDD
Remote Imaging System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class I
CE/MDR
QLAB Quantification System
Philips Ultrasound LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Vue PACS
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDD
GUDID
on market
QXLink
Vieworks Co., Ltd.
·
,
South Korea
Class IIa
FDA 510(k)
×3
K132302
Active
Cleared 12 Sep 2013
CE/MDD
+1
authorizations
3Dnet
Biotronics 3D Limited
·
,
United Kingdom
Class IIa
CE/MDR
Centricity Radiology RA600 v8.0 +2 more models
GE Healthcare
·
,
United States
Class IIa
CE/MDD
GUDID
on market
Enterprise Imaging XERO Viewer
Agfa HealthCare NV
·
,
Belgium
Class IIa
CE/MDR
28620117074
Expired
Valid to Aug 2026
FDA 510(k)
K252199
Active
Cleared 15 Oct 2025
+1
authorizations
neaLink
Vitec Neagen Oy
·
,
Finland
Class IIa
CE/MDD
Dicompass Camera 2
MEDORO s.r.o.
·
,
Czechia
Class IIb
CE/MDR
2022-MDR/QS-020
Expiring
Valid to Sep 2027
Sicat Endo V2.0.40
SICAT GmbH & Co. KG
·
,
Germany
Class IIa
FDA 510(k)
K180262
Active
Cleared 12 Mar 2018
CE/MDR
+1
authorizations
Vitrea Read
Canon Medical Informatics A/S
·
,
Denmark
Class IIa
CE/MDR
28620128868
Expiring
Valid to Apr 2027
GUDID
on market
Visage Breast Density
Visage Imaging, Inc.
·
,
Germany
Class IIa
FDA 510(k)
K201411
Active
Cleared 29 Jan 2021
CE/MDR
+1
authorizations
syngo.share webview diagnostic
ITH icoserve technology for healthcare GmbH
·
,
Austria
Class IIa
CE/MDD
CE/MDR
Telemis
Telemis S.A.
·
,
Belgium
Class IIa
FDA 510(k)
K032157
Active
Cleared 24 Sep 2003
CE/MDD
JiveX
VISUS Health IT GmbH
·
,
Germany
Class IIa
CE/MDD
FDA 510(k)
×2
K181964
Active
Cleared 23 Oct 2018
+1
authorizations
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