510(k) Report

FDA applicant

Visia Imaging S.R.L.

San Giovanni Valdarno, IT4 decisions2014–20230 recalls

FDA records 4 decisions for Visia Imaging S.R.L. (San Giovanni Valdarno, IT) from 2014 to 2023: 4 510(k) clearances. Most are in product codes HJO (Biomicroscope, Slit-Lamp, Ac-Powered) and MXK (Device, Analysis, Anterior Segment). 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, ophthalmic panel, where it files most

How often FDA has decided Visia Imaging S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014: 12016: 12022: 12023: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Visia Imaging S.R.L. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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