InkSpace Imaging Small Body Array (SBA12PH30x)

InkSpace Imaging Small Body Array (SBA12PH30x) is an FDA 510(k)-cleared medical device (K253182) manufactured by Inkspace Imaging, 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 October 19, 2025. Regulation: 8.