K060867

Substantially Equivalent

SPY INTRAOPERATIVE IMAGING SYSTEM

Applicant: Novadaq Technologies, Inc.
Product code: IZI
Advisory panel: Radiology
Date received: 2006-03-30
Decision date: 2006-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.