MYN · Class II · 21 CFR 892.2070

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., Overjet, Inc. and Imagen Technologies, Inc..

Total

Cleared

218d

Avg days

2021

Since

Growing category - 19 submissions in the last 2 years vs 13 in the prior period

Review times improving: avg 200d recently vs 236d historically

FDA 510(k) Cleared Analyzer, Medical Image Devices (Product Code MYN)

37 devices

1–24 of 37

Cleared May 11, 2026

Velmeni for Dentists (V4D) Endo-Perio

Dentsply Sirona, Inc.

Nobel Biocare C/O Medicim NV

Radiology · 138d

Cleared Nov 14, 2025

Second Opinion® Panoramic

VELMENI for DENTISTS (V4D)

Second Opinion® Pediatric

Second Opinion Periapical Radiolucency Contours

Better Diagnostics Caries Assist (BDCA) Version 1.0

K241725

Better Diagnostics AI Corp.

Velmeni for Dentists (V4D)

Overjet Caries Assist-Pediatric

Denti.Ai Technology, Inc.

Radiology · 261d

Cleared Oct 05, 2023

DeepTek CXR Analyzer v1.0

K231001

Deeptek Medical Imaging Pvt, Ltd.

Radiology · 181d

About Product Code MYN - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code MYN since 2021, with 37 receiving FDA clearance (average review time: 218 days).

Submission volume has increased in recent years - 19 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MYN Product Code

Recent submissions under MYN have taken an average of 200 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 →

FDA Product Code MYN: Analyzer, Medical Image

FDA 510(k) Cleared Analyzer, Medical Image Devices (Product Code MYN)

About Product Code MYN - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - MYN Product Code

Related FDA 510(k) Regulatory Insights