ORTHOCAD SOFTWARE OPTION— 510(k) K120288

Substantially Equivalent

Esaote, S.p.A.

FDA 510(k) clearance K120288 for ORTHOCAD SOFTWARE OPTION, Substantially Equivalent on 2012-09-19. Applicant: Esaote, S.p.A..

Clearance details

Applicant: Esaote, S.p.A.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-01-31
Decision date: 2012-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.