QRG — Ultrasound Guided Nerve Block Assist Class II
FDA product code QRG covers "Ultrasound Guided Nerve Block Assist", a Class II medical device regulated under 21 CFR 868.1980. Submissions are reviewed by the Anesthesiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QRG
- Device Class
- Class II
- Regulation Number
- 868.1980
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250818 | smart alfa teknoloji san. ve tic. a.s | Nerveblox | August 15, 2025 |
| K232787 | intelligent ultrasound limited | ScanNav Anatomy Peripheral Nerve Block | October 6, 2023 |
| DEN220024 | intelligent ultrasound limited | ScanNav Anatomy Peripheral Nerve Block | October 18, 2022 |