FDA Clears GE HealthCare’s Photonova Spectra Photon-counting CT

March 23, 2026 — GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Photonova Spectra,1 a photon‑counting computed tomography (PCCT) solution powered by the company’s Deep Silicon detector technology and offered as a flexible platform with multiple configurations to meet diverse clinical needs.