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Bioimaging and radiotherapy instruments
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Digital bioimaging management instruments
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Various digital bioimaging management instruments
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Various digital bioimaging management instruments - medical device software
Various digital bioimaging management instruments - medical device software
Z11069092
204 devices
IB Clinic
Imaging Biometrics, LLC
·
,
United States
Class I
FDA 510(k)
K123302
Active
Cleared 11 Jan 2013
CE/MDD
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
DaTQUANT
GE Medical Systems Israel, Functional Imaging
·
,
Israel
Class IIa
CE/MDD
GUDID
on market
Spine Planning, 2.0
Brainlab SE
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
IB Lab FROG
IB Lab GmbH
·
,
Austria
Class IIa
CE/MDR
Brainlab Elements - Guide XT, 3.0
Brainlab SE
·
,
Germany
Class IIa
FDA 510(k)
K213930
Active
Cleared 19 Apr 2022
CE/MDD
+1
authorizations
Medxr
Med.e.com
·
,
France
Class IIa
CE/MDR
FR25/00000027
Active
Valid to Jan 2030
M-Score Clinic Portal
M-Score Bone Health Srl
·
,
Italy
Class I
CE/MDR
TESI.View
O3 Enterprise srl
·
,
Italy
Class IIa
CE/MDR
Pathological image process software
SenseCare Smart Health Technology Co., Ltd.
·
,
China
Class I
CE/MDR
syngo.via
Siemens Healthcare GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
Ultima Print To PACS
MPTronic
·
,
France
Class I
CE/MDR
VUNO Med-LungCT AI
VUNO Inc.
·
,
South Korea
Class IIa
CE/MDR
KBA3D
S.M.A.I.O
·
,
France
Class IIa
FDA 510(k)
K223841
Active
Cleared 30 May 2023
CE/MDR
+1
authorizations
aiOS
Aidoc Medical Ltd
·
,
Israel
Class I
CE/MDR
GUDID
on market
MERLIN Diagnostic Workcenter
Phönix-PACS GmbH
·
,
Germany
Class I
CE/MDD
Veye Lung Nodules
Aidence B.V.
·
,
Netherlands
Class IIb
CE/MDR
SCAR-15.2.1.1
Active
Valid to Oct 2030
Lunit INSIGHT DBT
Lunit Inc.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
D-viewer
O3 Enterprise srl
·
,
Italy
Class IIa
CE/MDR
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