Product code QRG

Device name

Ultrasound Guided Nerve Block Assist

Medical specialty

Anesthesiology

Device class

2

Regulation number

868.1980

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset