Applied Spectral Imaging, Ltd.
Carlsbad, CA, US
APPLIED SPECTRAL IMAGING, LTD. appears in FDA device records in Carlsbad, CA. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Applied Spectral Imaging, Ltd. between 1997 and 2015. The busiest year on record is 1997, with 1. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2001 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140957 | GENASIS HIPATH IHC FAMILY | NQN | Substantially Equivalent | |
| K122554 | GENASIS SCANVIEW SYSTEM | NTH | Substantially Equivalent | |
| K110345 | SCANVIEW SYSTEM | NTH | Substantially Equivalent | |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | NTH | Substantially Equivalent | |
| K071398 | SCANVIEW, MODEL SC-300 | JOY | Substantially Equivalent | |
| K050236 | FISHVIEW | LNJ | Substantially Equivalent | |
| K012103 | BANDVIEW SYSTEM | LNJ | Substantially Equivalent | |
| K973950 | RETINAL CUBE | HKI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615060 | 3009505338 | APPLIED SPECTRAL IMAGING, LTD. | 2 HaCarmel St., Yokneam Northern 2069204 IL | 2026 | |
| 3002691099 | 3002691099 | Applied Spectral Imaging Inc. | 6160 Innovation Way, Carlsbad, CA 92008 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LNJAnalyzer, Chromosome, Automated
- HKICamera, Ophthalmic, Ac-Powered
- JOYDevice, Automated Cell-Locating
- IBJLight, Microscope
- NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
- NOTMicroscope, Automated, Image Analysis, Operator Intervention
- NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain