Data / Medical devices / United States / Leica Biosystems Imaging, Inc.
Leica Biosystems Imaging, Inc.: FDA-registered device maker in Vista, CA, United States, 4 510(k) clearances
Leica Biosystems Imaging, Inc. is registered with the FDA (registration 3006791373) in Vista, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 7, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006791373
- Address
- 1360 Park Center Drive, Vista, CA, United States, 92081
- Owner or operator
- Leica Biosystems, division of Leica Microsystems, Inc. (10054155)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- February 9, 2024
- Registered through
- 2026
- Brand names listed
- Aperio GT 180 DX, Aperio GT 450 DX, Aperio HALO AP, Aperio HALO AP DX, Aperio iQC DX Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Pathology Image Artifact Detection Software Device | SIX | 2 | Manufacturer | accessdata.fda.gov |
| Digital Pathology Image Viewing And Management Software | QKQ | 2 | Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
| Whole Slide Imaging System | PSY | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2026 | K253561 | Aperio iQC DX Software | SIX | Substantially Equivalent | Leica Biosystems Imaging, Inc. | accessdata.fda.gov |
| August 7, 2026 | K253554 | Aperio GT 450 DX; Aperio GT 180 DX | PSY | Substantially Equivalent | Leica Biosystems Imaging, Inc. | accessdata.fda.gov |
| November 25, 2025 | K252762 | HALO AP Dx | QKQ | Substantially Equivalent | Indica Labs, LLC | accessdata.fda.gov |
| April 16, 2024 | K232202 | Aperio GT 450 DX | PSY | Substantially Equivalent | Leica Biosystems Imaging, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 10, 2018 | 83383 | Class II | Terminated | Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. | The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis algorithm results, as well as potentially impact the visual appearance of whole slide images. | accessdata.fda.gov |
| February 7, 2014 | 67418 | Class II | Terminated | 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, viewing and analysis | In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products i | accessdata.fda.gov |
| February 22, 2013 | 33728 | Class II | Terminated | Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue speci | Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures. | accessdata.fda.gov |
Compare with other makers
- All makers of Whole Slide Imaging System
- All makers of Digital Pathology Image Viewing And Management Software
Updated August 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.