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 Samsung Electronics Co., Ltd., Nobel Biocare AB and Dentsply Sirona, Inc..

3
Total
3
Cleared
276d
Avg days
2021
Since

List of Analyzer, Medical Image devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Jan 07, 2026
DS Core Detect
K253009
Dentsply Sirona, Inc.
Radiology · 110d
Cleared Mar 28, 2023
DTX Studio Clinic 3.0
K221921
Nobel Biocare AB
Radiology · 270d
Cleared Aug 31, 2021
Auto Lung Nodule Detection
K201560
Samsung Electronics Co., Ltd.
Radiology · 447d

How to use this database

This page lists all FDA 510(k) submissions for Analyzer, Medical Image devices (product code MYN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Radiology FDA review panel. Browse all Radiology devices →