Medical Device Manufacturer · CN , Nanjing

Augment Intelligent Medical System (China) Co., Ltd. - FDA 510(k) Cle...

2 submissions · 2 cleared · Since 2022

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Augment Intelligent Medical System (China) Co., Ltd. Radiology ✕

2 devices

1-2 of 2

Cleared Sep 11, 2025

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

Radiology · 402d

Cleared Nov 22, 2022

Minimally Invasive Prostate Surgery Navigation System

Radiology · 183d