FDA product code NTH: System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
NTH is the FDA product code for system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays. It is a Class II device, regulated under 21 CFR 866.4700 and reviewed by the Pathology panel. FDA has cleared 7 510(k) submissions under NTH, from 5 different applicants. The average 510(k) review took 211 days (median 199). 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays |
| Device class | Class II |
| Regulation | 21 CFR 866.4700 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NTH clearance
Top NTH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Applied Spectral Imaging , Ltd. | 2 | 2013-02-07 |
| Applied Imaging Corp. | 2 | 2005-04-25 |
| Bioview , Ltd. | 1 | 2014-05-09 |
| Applied Spectral Imaging | 1 | 2011-10-19 |
| Ikonisys, Inc. | 1 | 2008-10-17 |
Most recent NTH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130775 | Bioview , Ltd. | DUET SYSTEM | 2014-05-09 | 415 |
| K122554 | Applied Spectral Imaging , Ltd. | GENASIS SCANVIEW SYSTEM | 2013-02-07 | 170 |
| K110345 | Applied Spectral Imaging | SCANVIEW SYSTEM | 2011-10-19 | 257 |
| K101291 | Applied Spectral Imaging , Ltd. | SCANVIEW HER2/NEU FISH SYSTEM | 2010-11-23 | 200 |
| K080909 | Ikonisys, Inc. | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | 2008-10-17 | 199 |
Recalls for NTH devices
openFDA lists no recalls for product code NTH.
Frequently asked questions
What is FDA product code NTH?
NTH is the FDA product code for system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays. It is a Class II device, regulated under 21 CFR 866.4700 and reviewed by the Pathology panel.
What device class is NTH?
Class II, regulation 21 CFR 866.4700. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTH?
Across 7 cleared submissions the average was 211 days from receipt to decision (median 199).
Which companies have the most NTH clearances?
Applied Spectral Imaging , Ltd. (2); Applied Imaging Corp. (2); Bioview , Ltd. (1); Applied Spectral Imaging (1); Ikonisys, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NTH
- Run a recall and safety report across every NTH manufacturer
- Watch product code NTH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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