Medical Device Manufacturer · US , Greenwood Village , CO

Ultrasound AI - FDA 510(k) Cleared Devices

1 submissions · 0 cleared · Since 2026

1

Total

0

Cleared

1

Denied

FDA 510(k) Regulatory Record - Ultrasound AI Radiology ✕

1 devices

1-1 of 1

Not Cleared Feb 11, 2026

Delivery Date AI

DEN250007 · SHE

Radiology · 331d