Company profile

NeuroSpectrum Insights Corp.

NeuroSpectrum Insights Corp. has 1 AI-enabled medical device on the FDA list. The first decision was on July 22, 2025 and the most recent on July 22, 2025 (GyriCalc (Version 1.0.0)). Its most common review panel is Radiology (1 device).

1AI devices

2025First decision

2025Latest decision

1Specialties

Timeline

July 22, 2025 · 510(k) K250686GyriCalc (Version 1.0.0) · Radiology · LLZ