DeviceClearance

Product code MYN— Radiology

Lung-CAD

Classification name
Analyzer, Medical Image
Device class
Class 2
Regulation
21 CFR 892.2070
Advisory panel
Radiology
Total cleared
40
First cleared
Most recent

FDA classification definition

“For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers”

— U.S. Food and Drug Administration, device classification record for product code MYN under 21 CFR 892.2070, via openFDA

Market context for product code MYN

FDA has cleared 40 devices under product code MYN between 2021 and 2026, filed by 21 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 MYN

Recent clearances under product code MYN

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