Ultrasound Guided Nerve Block Assist

QRG · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1980

Classification

FDA Product Code: QRG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 868.1980
Review panel: AN
Medical specialty: Anesthesiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 3
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown