Company ยท IL
Applied Spectral Imaging , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2015. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 3 |
| LNJ | Analyzer, Chromosome, Automated | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 |
| JOY | Device, Automated Cell-Locating | 1 |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2015 | K140957 | GENASIS HIPATH IHC FAMILY Applied Spectral Imaging , Ltd., IL | NQN |
| Feb 7, 2013 | K122554 | GENASIS SCANVIEW SYSTEM Applied Spectral Imaging , Ltd., IL | NTH |
| Oct 19, 2011 | K110345 | SCANVIEW SYSTEM Applied Spectral Imaging, IL | NTH |
| Nov 23, 2010 | K101291 | SCANVIEW HER2/NEU FISH SYSTEM Applied Spectral Imaging , Ltd., IL | NTH |
| Oct 4, 2007 | K071398 | SCANVIEW, MODEL SC-300 Applied Spectral Imaging , Ltd., IL | JOY |
| Jun 27, 2005 | K050236 | FISHVIEW Applied Spectral Imaging , Ltd., IL | LNJ |
| Sep 14, 2001 | K012103 | BANDVIEW SYSTEM Applied Spectral Imaging , Ltd., IL | LNJ |
| Dec 12, 1997 | K973950 | RETINAL CUBE Applied Spectral Imaging , Ltd., IL | HKI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||