510(k) DEN220024
DEN220024 is an FDA 510(k) premarket notification submitted by Intelligent Ultrasound Limited for the device "ScanNav Anatomy Peripheral Nerve Block". The FDA issued a decision of De Novo Granted on October 18, 2022. The device falls under product code QRG (Ultrasound Guided Nerve Block Assist), a Class II device regulated under 21 CFR 868.1980. Intelligent Ultrasound Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 18, 2022
- Date Received
- April 8, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound Guided Nerve Block Assist
- Device Class
- Class II
- Regulation Number
- 868.1980
- Review Panel
- AN
- Submission Type
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.