Devices · Intelligent Ultrasound Limited

ScanNav Anatomy Peripheral Nerve Block

Intelligent Ultrasound Limited is listed for ScanNav Anatomy Peripheral Nerve Block (DEN220024). The FDA list gives October 18, 2022 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QRG as “Ultrasound Guided Nerve Block Assist”: This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN220024

Official FDA database record

Date of final decision

October 18, 2022

Company on the FDA list

Intelligent Ultrasound Limited

Lead panel

Anesthesiology

Primary product code

QRG

openFDA device name for the code

Ultrasound Guided Nerve Block Assist

Device class

2

Regulation number

868.1980

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned