K111434

Substantially Equivalent

GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L

Applicant: Giotto USA, LLC
Product code: MUE
Advisory panel: Radiology
Date received: 2011-05-23
Decision date: 2011-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, US

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.