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In vitro diagnostic medical devices
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IVD instruments
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Hematology / histology / cytology instruments
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Histology / cytology
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Laboratory instruments for microscopic investigations
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Digital laboratory microscopes
Digital laboratory microscopes
W0202050304
113 devices
Solo Offline Workstation with Touch Screen
BioView Ltd.
·
,
Israel
Class A
CE/IVDR
PANNORAMIC 480 DX Digital Scanner
3DHISTECH Kft.
·
,
Hungary
Class A
CE/IVDR
GSL120 scan system BF FL
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
VS200-Bu-L-V2-Ivd
Evident Technology Center Europe GmbH
·
,
Germany
Class A
CE/IVDR
PANNORAMIC 75 DX Digital Scanner
3DHISTECH Kft.
·
,
Hungary
Class A
CE/IVDR
Ned-Dh
NTP Nano Tech Projects s.r.l.
·
,
Italy
Class A
CE/IVDR
GUDID
on market
GSL10 scan system BF
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
Konan CellChek D CD-15
Konan Medical, Inc.
·
,
Japan
Class A
CE/IVDR
GUDID
on market
Philips IntelliSite Pathology Solution 5.x - IVDR
Philips Medical Systems Nederland B.V.
·
,
Netherlands
Class A
FDA 510(k)
×3
K241871
Active
FDA De Novo
DEN160056
Active
Cleared 12 Apr 2017
+2
authorizations
Allegro Plus
BioView Ltd.
·
,
Israel
Class A
CE/IVDR
iO:M8
PreciPoint GmbH
·
,
Germany
Class A
CE/IVDR
NanoZoomer S360MD Slide scanner system
Open recall
Hamamatsu Photonics K.K., Systems Division
·
,
Japan
Class A
FDA 510(k)
×2
K233027
Active
Cleared 22 Dec 2023
CE/IVDR
CytoVision DX
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
SOLOWEB Server for 10 Concurrent Users
BioView Ltd.
·
,
Israel
Class A
CE/IVDR
TissueScope LE
Huron Technologies International Inc.
·
,
Canada
Class A
CE/IVDR
VS200-Bu-V2-Ivd
Evident Technology Center Europe GmbH
·
,
Germany
Class A
CE/IVDR
PANNORAMIC 1000 Digital Scanner
3DHISTECH Kft.
·
,
Hungary
IVD General
CE/IVDD
SlideVault
Huron Technologies International Inc.
·
,
Canada
Class A
CE/IVDR
Accord
BioView Ltd.
·
,
Israel
Class A
CE/IVDR
Aperio GT 450 SAM DX Software
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
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