MUE · Class II · 21 CFR 892.1715

FDA Product Code MUE: Full Field Digital, System, X-ray, Mammographic

Under FDA product code MUE, full-field digital mammography systems are cleared for breast cancer screening and diagnostic imaging.

These systems have replaced screen-film mammography as the standard of care, offering superior image quality, lower radiation dose, and the ability to apply digital image processing and AI detection algorithms. They capture digital images of the entire breast in a single compression.

MUE devices are Class II medical devices, regulated under 21 CFR 892.1715 and reviewed by the FDA Radiology panel.

Leading manufacturers include Ge Healthcare, Siemens Medical Solutions USA, Inc. and Vieworks Co., Ltd..

Total

Cleared

182d

Avg days

2011

Since

Growing category - 5 submissions in the last 2 years vs 3 in the prior period

Consistent review times: 168d avg (recent)

FDA 510(k) Cleared Full Field Digital, System, X-ray, Mammographic Devices (Product Code MUE)

54 devices

1–24 of 54

Cleared May 28, 2026

Bellalun 2D (VDMS-1000S)

GE Medical Systems SCS

Siemens Medical Solutions USA, Inc.

Planmed Clarity 2D, Planmed Clarify S

Planmed Clarity 2D and Clarity S

Giotto Class (Models - 3000X-YY and 4000X-YY)

Siemens Medical Solutions USA, Inc.

Radiology · 210d

Cleared May 15, 2020

Pristina Serena Bright

Sample Imaging for Senographe Pristina

Siemens Medi Cal Solutions, Inc.

About Product Code MUE - Regulatory Context

510(k) Submission Activity

54 total 510(k) submissions under product code MUE since 2011, with 54 receiving FDA clearance (average review time: 182 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MUE Product Code

FDA review times for MUE submissions have been consistent, averaging 168 days recently vs 183 days historically.

MUE devices are reviewed by the Radiology panel. Browse all Radiology devices →

FDA Product Code MUE: Full Field Digital, System, X-ray, Mammographic

FDA 510(k) Cleared Full Field Digital, System, X-ray, Mammographic Devices (Product Code MUE)

About Product Code MUE - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - MUE Product Code

Related FDA 510(k) Regulatory Insights