Laminar P1 (LDH-HW-001)

Laminar P1 (LDH-HW-001) is an FDA 510(k)-cleared medical device (K242487) manufactured by Laminar Digital Health, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2024. Regulation: 8.