Philips receives FDA clearance for Rembra CT platform

Philips has received FDA 510(k) clearance for its Rembra platform of CT scanning systems, including Rembra CT, Rembra RT, and Areta RT.

The FDA database lists the clearance under 510(k) K252992. The device names are CT Rembra RT, CT Areta RT, and CT Rembra.

Rembra CT is intended for diagnostic imaging. Philips said the system features an 85-cm bore and is designed for high-throughput imaging in emergency, critical care, and interventional settings.

The company said the diagnostic system can support up to 270 exams per day. Philips based the figure on a 16-hour day and throughput testing with 203 patient scans over 12 hours using typical radiology profiles and protocols.

Rembra RT and Areta RT are designed for radiation therapy planning. The systems feature an 85-cm extended field of view and next-generation 4D CT imaging capabilities, according to Philips.

Philips said the radiation therapy systems are intended to support tumor targeting while helping protect healthy tissue. The extended field of view is intended only for treatment preparation and radiation therapy planning or simulation, not diagnostic use.

The 510(k) summary describes the cleared products as computed tomography x-ray systems intended to produce images of the head and body by computer reconstruction of x-ray transmission data. The FDA listed the decision date as March 23, 2026.