Company profile

NICo-Lab B.V.

NICo-Lab B.V. has 2 AI-enabled medical devices on the FDA list. The first decision was on November 20, 2020 and the most recent on December 14, 2023 (StrokeViewer Perfusion). Its most common review panel is Radiology (2 devices).

2AI devices

2020First decision

2023Latest decision

1Specialties

Related guides

Top radiology devices

Timeline

December 14, 2023 · 510(k) K231570StrokeViewer Perfusion · Radiology · LLZ
November 20, 2020 · 510(k) K200873HALO · Radiology · QAS