DeviceClearance

Product code OAS— Radiology

RCT800

Classification name
X-Ray, Tomography, Computed, Dental
Device class
Class 2
Regulation
21 CFR 892.1750
Advisory panel
Radiology
Total cleared
135
First cleared
Most recent

FDA classification definition

“Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.”

— U.S. Food and Drug Administration, device classification record for product code OAS under 21 CFR 892.1750, via openFDA

Market context for product code OAS

FDA has cleared 135 devices under product code OAS between 2001 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 OAS

Recent clearances under product code OAS

1–100 of 135

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