FDA applicant

Leica Biosystems Imaging, Inc.

Vista, CA5 decisions2014–20261 recall

FDA records 5 decisions for Leica Biosystems Imaging, Inc. (Vista, CA) from 2014 to 2026: 5 510(k) clearances. Most are in product codes PSY (Whole Slide Imaging System) and NOT (Microscope, Automated, Image Analysis…). Its devices cite 6 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Leica Biosystems Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014high 2 (2026) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2018

2014high 1 (2018) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Leica Biosystems Imaging, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Leica Biosystems Imaging, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Leica”

FDA records each applicant name separately; these may or may not be the same firm.

Leica Biosystems Newcastle, Ltd. 6 Leica Microsystems (Schweiz) AG 4 Leica, Inc. 3 Leica Microsystems, Inc. 2 Leica Biosystems 1 Leica Microsystems, Inc. O.I.D. 1 Leica Microscopy Systems, Ltd. 1 Leica Biosystems Richmond 1

Leica Biosystems Imaging, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Leica”