DEN220024 is an FDA 510(k) submission for the ScanNav Anatomy Peripheral Nerve Block. This device is classified as a Ultrasound Guided Nerve Block Assist (Class II - Special Controls, product code QRG).
Submitted by Intelligent Ultrasound Limited (Cardiff, GB). The FDA issued a Not Cleared (DENG) decision on October 18, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1980. This Device Provides Real-time Interpretation And Enhanced Visualization Of Live Ultrasound Images By Highlighting Anatomical Landmarks In Preparation For Performing Regional Anesthesia..
| 510(k) Number | DEN220024 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 08, 2022 |
| Decision Date | October 18, 2022 |
| Days to Decision | 193 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | QRG - Ultrasound Guided Nerve Block Assist |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1980 |
| Definition | This Device Provides Real-time Interpretation And Enhanced Visualization Of Live Ultrasound Images By Highlighting Anatomical Landmarks In Preparation For Performing Regional Anesthesia. |