09:07 AM EST, 11/24/2025 (MT Newswires) -- GE HealthCare Technologies ( GEHC ) said Monday it has submitted a 510(k) application to the US Food and Drug Administration for Photonova Spectra, a photon-counting computed tomography system.

A 510(k) is a premarket notification submitted to the FDA to show that a new medical device is substantially equivalent to a legally marketed device, according to the FDA.

The company said the CT system is intended to streamline exam workflows with a single-scan approach and is aimed at a range of clinical uses, including neurological, cancer, cardiac, musculoskeletal and thoracic imaging.

The system is not yet cleared for sale in the US or other markets, the company said.