FDA applicant

Visus Health IT GmbH

Bochum, DE4 decisions2018–20230 recalls

FDA records 4 decisions for Visus Health IT GmbH (Bochum, DE) from 2018 to 2023: 4 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. No 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, radiology panel, where it files most

How often FDA has decided Visus Health IT GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Visus Health IT GmbH by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Visus”

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

Visus Technology Transfer GmbH 3

Visus Health IT GmbH

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Visus”