Applied Imaging Corp.: FDA clearances and approvals
Applied Imaging Corp. has 7 FDA 510(k) clearances (first 1990, latest 2005), across 5 product codes in 2 review panels. Median 510(k) review time: 126 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| JOY | Device, Automated Cell-Locating | 2 | 2 |
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 2 | 2 |
| LNJ | Analyzer, Chromosome, Automated | 1 | 1 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 1 | 1 |
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | 1 | 1 |
Review panels
- Pathology (5)
- Hematology (2)
Most recent Applied Imaging Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043519 | ARIOL HER-2/NEU FISH | NTH | 2005-04-25 | 126 |
| K042542 | CYTOVISION FOR CEP XY | NTH | 2005-01-10 | 112 |
| K033200 | ARIOL | NQN | 2004-03-18 | 168 |
| K031715 | ARIOL HER-2/NEU IHC | NOT | 2004-01-08 | 220 |
| K001420 | SLIDESCAN | JOY | 2000-08-30 | 117 |
| K980375 | WINSCAN AUTOMATED IMAGING SYSTEM | JOY | 1998-06-09 | 130 |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | LNJ | 1990-08-20 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Applied Imaging Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Applied Imaging Corp. have?
Applied Imaging Corp. has 7 FDA 510(k) clearances (first 1990, latest 2005), across 5 product codes in 2 review panels.
How long does FDA take to clear Applied Imaging Corp.'s 510(k)s?
The median time from FDA receipt to decision across Applied Imaging Corp.'s cleared 510(k)s is 126 days.
What devices does Applied Imaging Corp. make?
Its most frequent FDA product codes are JOY (Device, Automated Cell-Locating, 2); NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays, 2); LNJ (Analyzer, Chromosome, Automated, 1).
Has Applied Imaging Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Applied Imaging Corp. Related entities may recall under other names.
Next steps
- See all 7 Applied Imaging Corp. clearances with predicates and recalls
- Run predicate analysis for product code JOY, Applied Imaging Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.