Leica Biosystems Imaging, Inc.: FDA clearances and approvals
Leica Biosystems Imaging, Inc. has 5 FDA 510(k) clearances (first 2014, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time: 263 days. Since 2017 its median was 264 days, against 238 days for all cleared 510(k)s in the same product codes. openFDA lists 2 product recalls by a recalling firm named Leica Biosystems Imaging, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 91 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 95 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 266 |
| 2025 | 0 | — |
| 2026 | 2 | 264 |
Review time against the same product codes
Since 2017, Leica Biosystems Imaging, Inc.'s cleared 510(k)s took a median 264 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 238 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PSY | Whole Slide Imaging System | 3 | 3 |
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | 1 | 1 |
| SIX | Digital Pathology Image Artifact Detection Software Device | 1 | 1 |
Review panels
- Pathology (5)
Most recent Leica Biosystems Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253561 | Aperio iQC DX Software | SIX | 2026-08-07 | 263 |
| K253554 | Aperio GT 450 DX; Aperio GT 180 DX | PSY | 2026-08-07 | 266 |
| K232202 | Aperio GT 450 DX | PSY | 2024-04-16 | 266 |
| K190332 | Aperio AT2 DX System | PSY | 2019-05-20 | 95 |
| K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM | NOT | 2014-07-29 | 91 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-12-10.
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 Leica Biosystems Imaging, Inc. have?
Leica Biosystems Imaging, Inc. has 5 FDA 510(k) clearances (first 2014, latest 2026), across 3 product codes in 1 review panel.
How long does FDA take to clear Leica Biosystems Imaging, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Leica Biosystems Imaging, Inc.'s cleared 510(k)s is 263 days. Since 2017: 264 days, versus 238 days for all cleared 510(k)s in the same product codes.
What devices does Leica Biosystems Imaging, Inc. make?
Its most frequent FDA product codes are PSY (Whole Slide Imaging System, 3); NOT (Microscope, Automated, Image Analysis, Operator Intervention, 1); SIX (Digital Pathology Image Artifact Detection Software Device, 1).
Has Leica Biosystems Imaging, Inc. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Leica Biosystems Imaging, Inc; the most recent began 2018-12-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Leica Biosystems Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PSY, Leica Biosystems Imaging, 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.