FDA Radiology AI Devices

The Single Use Aspiration Needle models NA-201SX-4021 and NA-201SX-4022 by Olympus Medical Systems are sterile, disposable needles used alongside ultrasound endoscopes to perform fine needle aspiration of submucosal and extramural lesions in the tracheobronchial tree. They help clinicians obtain tissue samples safely and effectively under real-time ultrasound guidance.

ScanNav Anatomy Peripheral Nerve Block is a software that assists healthcare professionals in identifying and labeling anatomical structures in real-time ultrasound images during preparation for ultrasound-guided regional anesthesia. It uses deep learning AI to highlight key nerve block anatomical regions, improving procedural accuracy and safety.