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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
Disior Bonelogic 2.2
Disior Oy
·
,
Finland
Class IIa
CE/MDR
FI23/00000020
Active
Valid to May 2029
GUDID
on market
Volpara Scorecard
Lunit International Limited
·
,
New Zealand
Class I
CE/MDD
GUDID
on market
Centricity Enterprise Web 3.0
GE Healthcare
·
,
United States
Class I
CE/MDD
CardioDoc
Medsynaptic Pvt Ltd
·
,
India
Class I
CE/MDR
Centricity PACS - RA1000 v4.0
GE Healthcare
·
,
United States
Class IIa
CE/MDD
GUDID
on market
IntelliSpace Cardiovascular 5
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDR
2243163CE01
Active
Valid to Jul 2030
GUDID
on market
Philips FetView
Philips Ultrasound LLC
·
,
United States
Class I
CE/MDR
GUDID
on market
iRIS PACS
INFOMEDICA za proizvodnju i promet medicinskim proizvodima, društvo s ograničenom odgovornošću
·
,
Croatia
Class I
CE/MDR
Evocs
Fysicon B.V.
·
,
Netherlands
Class I
CE/MDR
synedra AIM 24 Herakles
synedra information technologies GmbH
·
,
Austria
Class IIb
CE/MDR
1000326253
Expiring
Valid to Dec 2026
CE/MDR
170780826
Withdrawn
Valid to Dec 2026
Sistem integrat PixelData PACS-RIS
PixelData SRL
·
,
Romania
Class I
CE/MDD
Dicompass Gateway
MEDORO s.r.o.
·
,
Czechia
Class IIb
CE/MDR
2022-MDR/QS-020
Expiring
Valid to Sep 2027
Bonelogic Neuro
Disior Oy
·
,
Finland
Class I
CE/MDD
Medical Image Post-processing Software
Shanghai United Imaging Healthcare Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Tomtec-Arena
Philips Ultrasound LLC
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Fusion Bx
Focal Healthcare Inc
·
,
Canada
Class IIa
FDA 510(k)
×2
K153166
Active
Cleared 25 Jan 2016
CE/MDR
+1
authorizations
Centricity PACS - RA1000 v3.0
GE Healthcare
·
,
United States
Class IIa
CE/MDD
Hy
Huiying Medical Technology (Beijing) Co., Ltd.
·
,
China
Class I
CE/MDR
IntelliSpace Cardiovascular 6
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class IIa
CE/MDR
2243163CE01
Active
Valid to Jul 2030
FDA 510(k)
K251215
Active
Cleared 2 Oct 2025
+1
authorizations
Fundus Image Processing Software
Hangzhou AI-MU Meditec Co., Ltd.
·
,
China
Class I
CE/MDR
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