NTHClass II
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
Immunology · 21 CFR 866.4700
MDR events2All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances8All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Malfunction2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Bioview , Ltd.May 9, 2014
K130775 · DUET SYSTEM
- Applied Spectral Imaging , Ltd.Feb 7, 2013
K122554 · GENASIS SCANVIEW SYSTEM
- Applied Spectral ImagingOct 19, 2011
K110345 · SCANVIEW SYSTEM
- Applied Spectral Imaging , Ltd.Nov 23, 2010
K101291 · SCANVIEW HER2/NEU FISH SYSTEM
- Ikonisys, Inc.Oct 17, 2008
K080909 · ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
- Applied Imaging Corp.Apr 25, 2005
K043519 · ARIOL HER-2/NEU FISH
- Applied Imaging Corp.Jan 10, 2005
K042542 · CYTOVISION FOR CEP XY
- VysisDec 13, 2004
DEN040010 · VYSIS AUTOVYSION SYSTEM