O-ARM IMAGING SYSTEM— 510(k) K092564

Substantially Equivalent

Medtronic Navigation, Inc. (Littleton)

FDA 510(k) clearance K092564 for O-ARM IMAGING SYSTEM, Substantially Equivalent on 2010-06-17. Applicant: Medtronic Navigation, Inc. (Littleton).

Clearance details

Applicant: Medtronic Navigation, Inc. (Littleton)
Product code: Code OXO
Advisory panel: Radiology
Date received: 2009-08-20
Decision date: 2010-06-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Littleton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OXO

product code OXO

Death: 6
Injury: 163
Malfunction: 2,099
Other: 1
Total: 2,269

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.