Applied Spectral Imaging , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Applied Spectral Imaging , Ltd.” (first 1997, latest 2015), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 158 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 170 |
| 2014 | 0 | — |
| 2015 | 1 | 276 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 3 | 3 |
| LNJ | Analyzer, Chromosome, Automated | 2 | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| JOY | Device, Automated Cell-Locating | 1 | 1 |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 1 | 1 |
Review panels
- Pathology (6)
- Hematology (1)
- Ophthalmic (1)
Most recent Applied Spectral Imaging , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140957 | GENASIS HIPATH IHC FAMILY | NQN | 2015-01-15 | 276 |
| K122554 | GENASIS SCANVIEW SYSTEM | NTH | 2013-02-07 | 170 |
| K110345 | SCANVIEW SYSTEM | NTH | 2011-10-19 | 257 |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | NTH | 2010-11-23 | 200 |
| K071398 | SCANVIEW, MODEL SC-300 | JOY | 2007-10-04 | 136 |
| K050236 | FISHVIEW | LNJ | 2005-06-27 | 147 |
| K012103 | BANDVIEW SYSTEM | LNJ | 2001-09-14 | 71 |
| K973950 | RETINAL CUBE | HKI | 1997-12-12 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Applied Spectral Imaging , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Applied Medical Resources (115 510(k)s)
- Applied Medical Technology, Inc. (25 510(k)s)
- Applied Medical Technologies (24 510(k)s)
- Applied Medical Research (22 510(k)s)
- Applied Vascular Devices, Inc. (21 510(k)s)
- Applied Osteo Systems, Inc. (15 510(k)s)
- Applied Medical (14 510(k)s)
- Applied Urology, Inc. (13 510(k)s)
- Applied Medical Devices, Inc. (11 510(k)s)
- Applied Laboratories, Inc. (9 510(k)s)
- Applied Biomaterial Technologies (7 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Spectral Imaging , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Applied Spectral Imaging , Ltd.” (first 1997, latest 2015), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Applied Spectral Imaging , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Spectral Imaging , Ltd. is 158 days.
Which FDA product codes appear under Applied Spectral Imaging , Ltd.?
The most frequent FDA product codes under this applicant name are 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).
Next steps
- See all 8 Applied Spectral Imaging , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NTH, Applied Spectral Imaging , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.