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.

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Regulatory Approvals

FDA
Nerveblox — 510(k) clearance (product code QRG)

K250818

Class II

Source ↗