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Reading: Philips receives FDA 510(k) clearance for its Rembra platform
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MedEdge MEA > Medical Equipment > Philips receives FDA 510(k) clearance for its Rembra platform
Medical Equipment

Philips receives FDA 510(k) clearance for its Rembra platform

ME Desk
ME Desk
Published: April 23, 2026
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April 2026- Philips has received 510(k) clearance from the U.S. Food and Drug Administration for its Rembra platform of scanning systems, which includes Rembra CT, Rembra RT, and Areta RT.

The newly cleared systems are designed to support healthcare providers in managing rising imaging demand and the growing complexity of clinical care by improving speed, workflow efficiency, and access to high-quality imaging. The platform also expands the use of CT across both diagnostic radiology and radiation therapy, helping create more connected workflows from emergency diagnosis to cancer treatment planning.

Rembra CT features an 85 cm bore, the largest in its class, and is built for high-volume clinical environments such as emergency departments, critical care units, and interventional settings. It can support up to 270 exams per day while delivering rapid and high-quality imaging to help clinicians make faster decisions in urgent situations.

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โ€˜โ€˜With the Rembra platform, we are redefining what clinicians can expect from CT, combining speed, scalability, and precision to expand access to high-quality imaging while supporting confident diagnosis and highly accurate treatment planning.โ€™โ€™ Said Dan Xu, Business Leader of CT at Philips

Rembra RT and Areta RT bring similar capabilities to radiation therapy, offering an 85 cm extended field of view and advanced 4DCT imaging for precise treatment planning. These systems are designed to improve tumor targeting, protect healthy tissue, and streamline simulation and planning workflows for more personalized cancer care.

Philips said the FDA clearances strengthen its CT portfolio and reflect its focus on combining advanced imaging technology with connected and intelligent workflows, supporting more coordinated care for patients and healthcare teams.

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