DeviceClearance

Product code OEB— Radiology

syngo.CT Lung CAD

Classification name
Lung Computed Tomography System, Computer-Aided Detection
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
20
First cleared
Most recent

FDA classification definition

“To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.”

— U.S. Food and Drug Administration, device classification record for product code OEB under 21 CFR 892.2050, via openFDA

Market context for product code OEB

FDA has cleared 20 devices under product code OEB between 2003 and 2026, filed by 16 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

Top applicants under product code OEB

Recent clearances under product code OEB

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