K232787 is an FDA 510(k) clearance 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 Cleared decision on October 6, 2023, 25 days after receiving the submission on September 11, 2023.
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 | K232787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2023 |
| Decision Date | October 06, 2023 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| 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. |