Atellica IM Total PSA II (tPSAII)

Atellica IM Total PSA II (tPSAII) is an FDA 510(k)-cleared medical device (K251630) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 2026. Regulation: 8.