510(k) K200424— Giotto Class (Models - 3000X-YY and 4000X-YY)

Substantially Equivalent

Ims Giotto S.P.A.

Clearance details

Applicant: Ims Giotto S.P.A.
Product code: Code MUE
Advisory panel: Radiology
Date received: 2020-02-20
Decision date: 2020-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Sasso Marconi, IT

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.