ClearPoint Array System (Version 1.2)

ClearPoint Array System (Version 1.2) is an FDA 510(k)-cleared medical device (K232102) manufactured by ClearPoint Neuro, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2023. Regulation: 8.