# Leica Biosystems Imaging, Inc. (manufacturer, Vista, CA): 3 new FDA device listings, incl. whole slide imaging system

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Leica Biosystems Imaging, Inc. |
| Owner / operator | Leica Biosystems, division of Leica Microsystems, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Manufacture Device in the United States for Export Only |
| Location | Vista, CA, US |
| New listings | 3 |
| Devices | Whole Slide Imaging System; Digital Pathology Image Artifact Detection Software Device; Digital Pathology Image Viewing And Management Software |
| Product codes | PSY, SIX, QKQ |
| Device classes | Class II |
| Medical specialties | Pathology |
| Brand names | Aperio GT 180 DX; Aperio GT 450 DX; Aperio iQC DX Software; Aperio HALO AP |
| First new listing | 2026-09-04 |
| Latest new listing | 2026-09-15 |
| FDA registration number | 3006791373 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.