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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
Lower Gastrointestinal Endoscopy Real-Time Image Processing Workstation Software
Tianjin Yujin Artificial Intelligence Medical Technology Co., Ltd.
·
,
China
Class I
CE/MDR
aycan store / aycan web
Aycan Digitalsysteme GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
GXD5 Pacs
Enovacom
·
,
France
Class I
CE/MDD
Opensight
Novarad Corporation
·
,
United States
Class IIa
FDA 510(k)
K172418
Active
Cleared 21 Sep 2018
CE/MDR
+1
authorizations
iPACS
Healthcare Experience Ανωνυμη Εταιρεια Ολοκληρωμενων Λυσεων Ιατρικης Πληροφορικης Ιατρικου Εξοπλιμου-Λογισμικου Και Υπηρεσιων
·
,
Greece
Class I
CE/MDR
Chili Pacs
NEXUS / CHILI GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Ophthalmology Images Processing System
Beijing Zhenhealth Technology Co., Ltd.
·
,
China
Class I
CE/MDR
Orca®
Oehm Und Rehbein GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
digipaX 2.2
digipaX GmbH
·
,
Germany
Class IIb
CE/MDR
Chili Pacs
NEXUS / CHILI GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Chili Pacs
NEXUS / CHILI GmbH
·
,
Germany
Class IIb
FDA 510(k)
K070796
Active
Cleared 6 Apr 2007
CE/MDR
+1
authorizations
SonoDoc SR
Medsynaptic Pvt Ltd
·
,
India
Class I
CE/MDR
Untire Now
Tired of Cancer BV
·
,
Netherlands
Class I
CE/MDR
Dentally Vision (previously marketed as Dentrix Ascend Imaging)
Henry Schein One, LLC
·
,
United States
Class I
CE/MDD
Navbit Rapid Surgical Plan
Navbit Pty Ltd
·
,
Australia
Class IIa
FDA 510(k)
K243447
Active
Cleared 5 Dec 2024
CE/MDR
DeepUnity PACSonWEB
DH Healthcare GmbH
·
,
Germany
Class IIa
CE/MDR
innoMEDIA
Iasis Technologies Ικε
·
,
Greece
Class I
CE/MDR
Ziostation2 Plus
Ziosoft, Inc.
·
,
Japan
Class IIa
FDA 510(k)
×3
K070205
Active
Cleared 23 Mar 2007
CE/MDD
QLAB Advanced Quantification Software
Philips Ultrasound LLC
·
,
United States
Class IIa
FDA 510(k)
×2
K040227
Active
Cleared 17 Feb 2004
CE/MDR
+1
authorizations
Novapacs
Novarad Corporation
·
,
United States
Class IIa
FDA 510(k)
×2
K171754
Active
Cleared 28 Jul 2017
CE/MDR
+1
authorizations
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