Ricoh 3D for Healthcare Bolus

Ricoh 3D for Healthcare Bolus is an FDA 510(k)-cleared medical device (K253025) manufactured by Ricoh 3D For Healthcare, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2026. Regulation: 8.