Photonova Spectra, Photonova Spectra Select

Photonova Spectra, Photonova Spectra Select is an FDA 510(k)-cleared medical device (K253520) manufactured by Ge Medical Systems, 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 March 19, 2026. Regulation: 8.