Giotto Class (Models - 3000X-YY and 4000X-YY)— 510(k) K200424
Substantially EquivalentIms Giotto S.P.A.
FDA 510(k) clearance K200424 for Giotto Class (Models - 3000X-YY and 4000X-YY), Substantially Equivalent on 2020-06-18. Applicant: Ims Giotto S.P.A.. Device class: 2.
Clearance details
- Applicant
- Ims Giotto S.P.A.
- Product code
- Code MUE
- Device class
- Class 2
- Regulation
- 21 CFR 892.1715
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sasso Marconi, IT
Recent devices under product code MUE
view allMore clearances from Ims Giotto S.P.A.
view allAdverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . 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.