Philips Receives FDA 510(k) Clearance for Rembra CT, RT, and Areta RT Platforms

PHG
April 22, 2026

Philips announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its Rembra platform, which includes the Rembra CT, Rembra RT, and Areta RT scanning systems. The clearance allows Philips to market these high‑throughput imaging solutions in the United States, expanding its CT portfolio into both diagnostic radiology and radiation‑therapy planning.

The Rembra CT features an 85‑cm bore and rapid acquisition capabilities that enable up to 270 examinations per day under typical clinical protocols. Rembra RT and Areta RT add an extended 85‑cm field of view and next‑generation 4D‑CT, providing precise imaging for cancer treatment planning. These technical advances position Philips to offer a unified, high‑performance CT ecosystem that spans urgent diagnosis to precision‑guided therapy.

Philips’ leadership highlighted the strategic importance of the clearance. Dan Xu, Philips’ Business Leader of CT, said, "As healthcare systems manage increasing demand and complexity, imaging plays a critical role in enabling timely and informed clinical decisions. 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." He added, "Rembra is built for the realities that clinicians face every day. By combining our most advanced detector technology with AI‑powered workflows and industry‑leading speed, Rembra represents a significant step forward for high‑acuity imaging, delivering speed, access and diagnostic confidence when it matters most."

The platform’s 85‑cm bore also improves procedural access. Professor Olivier Rouvière noted, "In interventional and high‑acuity settings, precise access and efficient positioning are essential. Rembra's 85 cm bore supports improved access as well as faster and safer positioning of long needles and instruments in complex procedures." Philips also emphasized its pioneering role in CT simulation, stating, "A new era of CT simulation is rising to meet the challenge." Dan Xu added, "Philips invented CT simulation and introduced the industry's first big‑bore RT system. With Rembra RT and Areta RT, we're once again setting new standards in radiation therapy, empowering care teams with the precision, dependability, and speed they need to deliver the best outcomes for patients."

The clearance removes a key regulatory barrier, enabling Philips to capture a larger share of the growing imaging and oncology markets. By integrating AI, extended field‑of‑view imaging, and high‑throughput capabilities, Philips strengthens its competitive position against rivals such as GE Healthcare and Siemens Healthineers, while reinforcing its strategy of delivering end‑to‑end solutions across the patient care pathway.

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