- All Devices
- Ultrasound
- Nerveblox
Ultrasound
Nerveblox
Smart Alfa Teknoloji San. Ve Tic. A.S.
FDA
FDA-cleared AI medical device
Software that identifies and labels anatomical structures on real-time ultrasound images, intended to support clinicians performing ultrasound-guided regional-anesthesia procedures.
FDA Submission Metadata
- Submission number
- K250818
- Decision date
- August 2025
- FDA panel
- Anesthesiology
- Product code
- QRG
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA