GE HealthCare Submits FDA Application for Photonova Spectra Imaging System
MT Newswires Live
Nov 24, 2025
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.
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