ScanNav Anatomy Peripheral Nerve Block is an AI-enabled medical device from Intelligent Ultrasound Limited that the U.S. FDA granted through De Novo DEN220024 on October 18, 2022. Its lead review panel is Anesthesiology and its primary product code is QRG (Ultrasound Guided Nerve Block Assist).
See also all FDA AI clearances in 2022, top anesthesiology AI devices.
Key facts
| Submission number | DEN220024 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Intelligent Ultrasound Limited |
| Lead review panel | Anesthesiology |
| Primary product code | QRG — Ultrasound Guided Nerve Block Assist |
| Applicant (openFDA) | Intelligent Ultrasound Limited |
| Applicant location | Cardiff, GB |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.1980 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. ScanNav Anatomy Peripheral Nerve Block went through this pathway (DEN220024).
openFDA lists it as a Class 2 device under 21 CFR 868.1980. Class II devices are moderate risk and are subject to general and special controls.
Product code QRG covers 3 devices on the FDA AI list. By decision date, this device is #1 of 3 under that code. Intelligent Ultrasound Limited has 2 AI-enabled devices on the list, and the Anesthesiology panel accounts for 30 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
Similar devices (product code QRG)
- NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S. · Anesthesiology
- ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · Anesthesiology