DeviceClearance

Product code OWB— Radiology

SyncVision System

Classification name
Interventional Fluoroscopic X-Ray System
Device class
Class 2
Regulation
21 CFR 892.1650
Advisory panel
Radiology
Total cleared
325
First cleared
Most recent

FDA classification definition

“Interventional fluoroscopy”

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

Market context for product code OWB

FDA has cleared 325 devices under product code OWB between 1991 and 2026, filed by 115 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 OWB

Adverse events under product code OWB

product code OWB
Death
49
Injury
340
Malfunction
36,973
Total
37,362

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 OWB

1–100 of 325

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