Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lumisys, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
283 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980809 | LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER | Lumisys, Inc. | 1998-05-11 | 69 | 0 |
| K980213 | DI-2000 | Lumisys, Inc. | 1998-03-17 | 67 | 0 |
| K953371 | LUMISYS DICOM TOOKLIT | Lumisys, Inc. | 1995-10-18 | 92 | 0 |
| K953964 | LUMISYS, LUMISCAN 20 | Lumisys, Inc. | 1995-09-18 | 27 | 0 |
| K933129 | LUMISCAN 50 | Lumisys, Inc. | 1993-10-07 | 101 | 0 |
| K902347 | COMPACT LASER IMAGER, MODEL CLI-100 | Lumisys, Inc. | 1991-03-04 | 283 | 0 |
| K901423 | DIGITAL IMAGE SCANNER, MODEL DIS-1000 | Lumisys, Inc. | 1990-04-30 | 35 | 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