GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L— 510(k) K111434

Name: FDA 510(k) clearance K111434
Creator: U.S. Food and Drug Administration
Published: 2011-10-27

Substantially Equivalent

Giotto USA, LLC

FDA 510(k) clearance K111434 for GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L, Substantially Equivalent on 2011-10-27. Applicant: Giotto USA, LLC. Device class: 2.

Clearance details

Applicant: Giotto USA, LLC
Product code: Code MUE
Device class: Class 2
Regulation: 21 CFR 892.1715
Advisory panel: Radiology
Date received: 2011-05-23
Decision date: 2011-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, US

Download summary PDF View on FDA.gov ↗

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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.