O-ARM IMAGING SYSTEM— 510(k) K050996

Name: FDA 510(k) clearance K050996
Creator: U.S. Food and Drug Administration
Published: 2005-05-05

Substantially Equivalent

Breakaway Imaging, LLC

FDA 510(k) clearance K050996 for O-ARM IMAGING SYSTEM, Substantially Equivalent on 2005-05-05. Applicant: Breakaway Imaging, LLC. Device class: 2.

Clearance details

Applicant: Breakaway Imaging, LLC
Product code: Code OXO
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2005-04-20
Decision date: 2005-05-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Littleton, MA, US

Download summary PDF View on FDA.gov ↗

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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.