Lumisys, Inc.: FDA clearances and approvals
Lumisys, Inc. has 7 FDA 510(k) clearances (first 1990, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time: 69 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 |
|---|---|---|---|
| LMA | Digitizer, Image, Radiological | 5 | 5 |
| LMC | Camera, Multi Format, Radiological | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Radiology (7)
Most recent Lumisys, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980809 | LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER | LMA | 1998-05-11 | 69 |
| K980213 | DI-2000 | LMA | 1998-03-17 | 67 |
| K953371 | LUMISYS DICOM TOOKLIT | LMD | 1995-10-18 | 92 |
| K953964 | LUMISYS, LUMISCAN 20 | LMA | 1995-09-18 | 27 |
| K933129 | LUMISCAN 50 | LMA | 1993-10-07 | 101 |
| K902347 | COMPACT LASER IMAGER, MODEL CLI-100 | LMC | 1991-03-04 | 283 |
| K901423 | DIGITAL IMAGE SCANNER, MODEL DIS-1000 | LMA | 1990-04-30 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Lumisys, Inc..
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 Lumisys, Inc. have?
Lumisys, Inc. has 7 FDA 510(k) clearances (first 1990, latest 1998), across 3 product codes in 1 review panel.
How long does FDA take to clear Lumisys, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lumisys, Inc.'s cleared 510(k)s is 69 days.
What devices does Lumisys, Inc. make?
Its most frequent FDA product codes are LMA (Digitizer, Image, Radiological, 5); LMC (Camera, Multi Format, Radiological, 1); LMD (System, Digital Image Communications, Radiological, 1).
Has Lumisys, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lumisys, Inc. Related entities may recall under other names.
Next steps
- See all 7 Lumisys, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LMA, Lumisys, Inc.'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.