Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chroma Vision Medical Systems, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032113 | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Chroma Vision Medical Systems, Inc. | 2003-12-23 | 167 | 0 |
| K012138 | MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | Chroma Vision Medical Systems, Inc. | 2002-09-30 | 447 | 0 |
| K984188 | AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) | Chroma Vision Medical Systems, Inc. | 1999-07-28 | 247 | 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