NTH
8 FDA 510(k) clearances · Product code
199 daysmedian time to decision
415 days90th percentile
8clearances measured
FDA profile
- Official device name
- System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.4700
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DUET SYSTEM (K130775) | Bioview , Ltd. | 2014-05-09 |
| GENASIS SCANVIEW SYSTEM (K122554) | Applied Spectral Imaging , Ltd. | 2013-02-07 |
| SCANVIEW SYSTEM (K110345) | Applied Spectral Imaging | 2011-10-19 |
| SCANVIEW HER2/NEU FISH SYSTEM (K101291) | Applied Spectral Imaging , Ltd. | 2010-11-23 |
| ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (K080909) | Ikonisys, Inc. | 2008-10-17 |
| ARIOL HER-2/NEU FISH (K043519) | Applied Imaging Corp. | 2005-04-25 |
| CYTOVISION FOR CEP XY (K042542) | Applied Imaging Corp. | 2005-01-10 |
| VYSIS AUTOVYSION SYSTEM (DEN040010) | Vysis | 2004-12-13 |
Track NTH automatically
Every clearance here is in the API, with alerts when new ones post.