510(k) K232787

ScanNav Anatomy Peripheral Nerve Block by Intelligent Ultrasound Limited — Product Code QRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2023
Date Received
September 11, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasound Guided Nerve Block Assist
Device Class
Class II
Regulation Number
868.1980
Review Panel
AN
Submission Type

This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.