Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Spectral Imaging , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
276 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140957 | GENASIS HIPATH IHC FAMILY | Applied Spectral Imaging , Ltd. | 2015-01-15 | 276 | 0 |
| K122554 | GENASIS SCANVIEW SYSTEM | Applied Spectral Imaging , Ltd. | 2013-02-07 | 170 | 0 |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | Applied Spectral Imaging , Ltd. | 2010-11-23 | 200 | 0 |
| K071398 | SCANVIEW, MODEL SC-300 | Applied Spectral Imaging , Ltd. | 2007-10-04 | 136 | 0 |
| K050236 | FISHVIEW | Applied Spectral Imaging , Ltd. | 2005-06-27 | 147 | 0 |
| K012103 | BANDVIEW SYSTEM | Applied Spectral Imaging , Ltd. | 2001-09-14 | 71 | 0 |
| K973950 | RETINAL CUBE | Applied Spectral Imaging , Ltd. | 1997-12-12 | 57 | 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