# Leica Biosystems Imaging, Inc.

- Location (FDA's records): Vista, CA
- FDA decisions: 5 (2014–2026): 5 510(k) clearances
- Product codes: PSY (3), NOT (1), SIX (1)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 15 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aperio Technologies: 2 (https://510kreport.com/company/aperio-technologies)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)

## Firms that cite its devices most
- Sectra AB: 2 (https://510kreport.com/company/sectra)
- Paige.Ai, Inc.: 1 (https://510kreport.com/company/paige-ai)
- Ventana Medical Systems, Inc.: 1 (https://510kreport.com/company/ventana-medical-systems)
- Inspirata, Inc.: 1 (https://510kreport.com/company/inspirata)
- Indica Labs, Inc.: 1 (https://510kreport.com/company/indica-labs)
- PathAI, Inc.: 1 (https://510kreport.com/company/pathai)
- Tribun Health: 1 (https://510kreport.com/company/tribun-health)
- Shenzhen Beacon Display Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-beacon-display-technology)

## Its most-cited devices
- K232202: Aperio GT 450 DX (2024), cited by 9
- K190332: Aperio AT2 DX System (2019), cited by 4
- K141109: Aperio Epathology Eihc Ivd System (2014), cited by 1
- K253554: Aperio GT 450 DX; Aperio GT 180 DX (2026), cited by 1

## Recent decisions
- K253561: Aperio iQC DX Software (Aug 7, 2026)
- K253554: Aperio GT 450 DX; Aperio GT 180 DX (Aug 7, 2026)
- K232202: Aperio GT 450 DX (Apr 16, 2024)
- K190332: Aperio AT2 DX System (May 20, 2019)
- K141109: Aperio Epathology Eihc Ivd System (Jul 29, 2014)

Source page: https://510kreport.com/company/leica-biosystems-imaging