GE HealthCare Technologies Inc. (NASDAQ: GEHC) received 510(k) clearance from the U.S. Food and Drug Administration for its Photonova Spectra photon-counting computed tomography system, the company announced.

The system uses GE HealthCare's Deep Silicon detector technology and features 8-bin energy resolution. Unlike conventional CT systems that convert X-ray photons into visible light before measuring them, photon-counting CT directly counts individual photons and measures their energy.

Photonova Spectra incorporates NVIDIA accelerated computing technology designed to handle up to 50 times more data than conventional CT systems. The system automatically captures both 8-bin spectral and ultra-high definition spatial data simultaneously without requiring special setup or multiple protocols.

The detector has wide coverage and rapid rotation speed of 0.23 seconds. The system is designed to fit into existing GE HealthCare CT rooms with minimal changes, preserving the mechanical, electrical, and workflow design used across the Revolution family.

GE HealthCare is collaborating with UW-Madison and Stanford Medicine on clinical evaluations and research. UW-Madison represents the first U.S. clinical evaluation site for the silicon-based photon-counting CT technology, while Stanford Medicine focuses on human subject and technical research efforts.

"Photonova Spectra is designed to deliver rich clinical insights in every scan and help alleviate cognitive burden for care teams," said Catherine Estrampes, President and CEO, U.S. and Canada, GE HealthCare.

The FDA clearance follows the system's debut at the Radiological Society of North America Annual Meeting in November 2025. GE HealthCare will begin preparing for commercial availability in the United States.

The development is part of the company's $5.1 billion innovation investment, which the company states is expected to contribute to 1-2% revenue growth through transformational products across its portfolio.