FDA Product Code MYN: Analyzer, Medical Image
Under FDA product code MYN, medical image analyzers are cleared for the quantitative analysis of radiological images.
These software systems perform automated measurements, segmentation, and quantification of structures visible in medical images — including organ volumes, lesion sizes, and tissue densities — providing reproducible quantitative data to supplement visual interpretation.
MYN devices are Class II medical devices, regulated under 21 CFR 892.2070 and reviewed by the FDA Radiology panel.
Leading manufacturers include Pearl, Inc., Velmeni, Inc. and AZmed.
FDA 510(k) Cleared Analyzer, Medical Image Devices (Product Code MYN)
About Product Code MYN - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code MYN since 2021, with 36 receiving FDA clearance (average review time: 217 days).
Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MYN have taken an average of 198 days to reach a decision - down from 236 days historically, suggesting improved FDA processing for this classification.
MYN devices are reviewed by the Radiology panel. Browse all Radiology devices →