Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Imaging Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
220 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043519 | ARIOL HER-2/NEU FISH | Applied Imaging Corp. | 2005-04-25 | 126 | 0 |
| K042542 | CYTOVISION FOR CEP XY | Applied Imaging Corp. | 2005-01-10 | 112 | 0 |
| K033200 | ARIOL | Applied Imaging Corp. | 2004-03-18 | 168 | 0 |
| K031715 | ARIOL HER-2/NEU IHC | Applied Imaging Corp. | 2004-01-08 | 220 | 0 |
| K001420 | SLIDESCAN | Applied Imaging Corp. | 2000-08-30 | 117 | 0 |
| K980375 | WINSCAN AUTOMATED IMAGING SYSTEM | Applied Imaging Corp. | 1998-06-09 | 130 | 0 |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | Applied Imaging Corp. | 1990-08-20 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda