Ultrasound Guided Nerve Block Assist
The Ultrasound Guided Nerve Block Assist is a software device providing real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks to assist clinicians in performing regional anesthesia nerve blocks. It is intended to reduce the difficulty and improve accuracy of nerve block procedures. Classified as FDA Class 2 under regulation 868.1980, it requires 510(k) clearance and is reviewed under the Anesthesiology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QRG
- Device Class
- FDA class 2
- Regulation Number
- 868.1980
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250818 | Nerveblox | Aug 15, 2025 | Substantially Equivalent | Smart Alfa Teknoloji San. Ve Tic. A.S. |
| K232787 | ScanNav Anatomy Peripheral Nerve Block | Oct 06, 2023 | Substantially Equivalent | Intelligent Ultrasound Limited |
| DEN220024 | ScanNav Anatomy Peripheral Nerve Block | Oct 18, 2022 | Unknown | Intelligent Ultrasound Limited |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.