FDA applicant

Ims Giotto S.P.A.

Sasso Marconi, IT2 decisions2020–20210 recalls

FDA records 2 decisions for Ims Giotto S.P.A. (Sasso Marconi, IT) from 2020 to 2021: 2 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and MUE (Full Field Digital, System, X-Ray, Mammographic). 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 Ims Giotto S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Ims Giotto S.P.A. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Ims Giotto S.P.A.

Which product codes does it file in?

What has FDA decided for it lately?