DeviceClearance

Product code OXO— Radiology

O-ARM IMAGING SYSTEM

Classification name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class
Class 2
Regulation
21 CFR 892.1650
Advisory panel
Radiology
Total cleared
82
First cleared
Most recent

FDA classification definition

“Fluoroscopy of the human body.”

— U.S. Food and Drug Administration, device classification record for product code OXO under 21 CFR 892.1650, via openFDA

Market context for product code OXO

FDA has cleared 82 devices under product code OXO between 1976 and 2026, filed by 47 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OXO

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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OXO

Data sourced from openFDA. This site is unofficial and independent of the FDA.