DeviceClearance

Product code POK— Radiology

Brainomix 360 e-ASPECTS

Classification name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device class
Class 2
Regulation
21 CFR 892.2060
Advisory panel
Radiology
Total cleared
23
First cleared
Most recent

FDA classification definition

“Assist users in characterizing lesions identified on acquired medical images”

— U.S. Food and Drug Administration, device classification record for product code POK under 21 CFR 892.2060, via openFDA

Market context for product code POK

FDA has cleared 23 devices under product code POK between 2017 and 2026, filed by 15 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 POK

Recent clearances under product code POK

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