NTH · Class II · 21 CFR 866.4700

FDA Product Code NTH: System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays

Leading manufacturers include Applied Imaging Corp., Applied Spectral Imaging , Ltd. and Vysis.

8
Total
7
Cleared
193d
Avg days
2004
Since

FDA 510(k) Cleared System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays Devices (Product Code NTH)

8 devices
1–8 of 8
Cleared May 09, 2014
DUET SYSTEM
K130775
Bioview , Ltd.
Pathology · 415d
Cleared Feb 07, 2013
GENASIS SCANVIEW SYSTEM
K122554
Applied Spectral Imaging , Ltd.
Pathology · 170d
Cleared Oct 19, 2011
SCANVIEW SYSTEM
K110345
Applied Spectral Imaging
Pathology · 257d
Cleared Nov 23, 2010
SCANVIEW HER2/NEU FISH SYSTEM
K101291
Applied Spectral Imaging , Ltd.
Pathology · 200d
Cleared Oct 17, 2008
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
K080909
Ikonisys, Inc.
Pathology · 199d
Cleared Apr 25, 2005
ARIOL HER-2/NEU FISH
K043519
Applied Imaging Corp.
Pathology · 126d
Cleared Jan 10, 2005
CYTOVISION FOR CEP XY
K042542
Applied Imaging Corp.
Hematology · 112d
Not Cleared Dec 13, 2004
VYSIS AUTOVYSION SYSTEM
DEN040010
Vysis
Pathology · 61d

About Product Code NTH - Regulatory Context