Company ยท US
Leica Biosystems Imaging, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (2 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2026 | K253561 | Aperio iQC DX Software Leica Biosystems Imaging, Inc. | SIX |
| Aug 7, 2026 | K253554 | Aperio GT 450 DX; Aperio GT 180 DX Leica Biosystems Imaging, Inc. | PSY |
| Apr 16, 2024 | K232202 | Aperio GT 450 DX Leica Biosystems Imaging, Inc. | PSY |
| May 20, 2019 | K190332 | Aperio AT2 DX System Leica Biosystems Imaging, Inc. | PSY |
| Jul 29, 2014 | K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM Leica Biosystems Imaging, Inc. | NOT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2019 | Leica Biosystems Imaging, Inc. Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. Terminated |
NOT | K141109 |
| Mar 7, 2014 | Leica Biosystems Imaging, Inc. HER2 Image Analysis
Manual Read of HER2 Digital Slides
ER/PR Image Analysis
IHC PR Breast Tissue Manual Read of Digital Slides
The ScanScope System is an automated digital slide creation, management, Terminated |
NOT | None listed |