Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
In vitro diagnostic medical devices
/
IVD instruments
/
Hematology / histology / cytology instruments
/
Histology / cytology
Histology / cytology
W020205
2,260 devices
Subcategories
4
W02020501
Histological samples analysers
4
devices
W02020502
Cervical screening systems
13
devices
W02020503
Laboratory instruments for microscopic investigations
1,427
devices
›
W02020590
Various processing instruments for hystology / cytology
816
devices
›
Devices
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
Mgu-30009
Grundium Oy
·
,
Finland
Class A
CE/IVDR
PANNORAMIC MIDI II Digital Scanner
3DHISTECH Kft.
·
,
Hungary
IVD General
CE/IVDD
VS200-Bu-V2-Ivd
Evident Technology Center Europe GmbH
·
,
Germany
Class A
CE/IVDR
Automated Hematology Slide Preparation Unit SP-50
Sysmex Corporation
·
,
Japan
Class A
CE/IVDR
Epredia E1000 Dx Digital Pathology Solution
Shandon Diagnostics Limited
·
,
United Kingdom
Class A
FDA 510(k)
K241717
Active
Cleared 28 Feb 2025
CE/IVDR
+1
authorizations
Karotyping and FISH Capture Workstations
Leica Biosystems Imaging, Inc.
·
,
United States
Class A
CE/IVDR
Previous
Next