FDA clears Philips Rembra CT platform for diagnostic, RT use
The clearance covers Rembra CT for diagnostic imaging and 2 radiation therapy planning systems, Rembra RT and Areta RT.
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.
Company:Philips
About the author
RadiologySignal.com writersEditorial Team
Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
More from this section
Niowave breaks ground on $75M Ac-225 production facility
The Lansing, MI, site will house superconducting linear accelerators and radiochemistry systems to support scalable actinium-225 production, with completion expected in 2028.
GE HealthCare, UW Medicine launch imaging research collaboration
The collaboration will focus on CT and molecular imaging technologies for cardiology, oncology, and theranostics workflows at UW Medicine Radiology facilities in Seattle.
Recall issues and isotope shortages weigh on Radnostix Q1 revenue
The radioisotope-focused company reported $2.38M in Q1 revenue, citing recall impacts, isotope shortages, and Cobalt-60 hot cell downtime.
Ephemeral to build AI data platform for Plus CNS oncology programs
The companies will develop an AI platform to integrate therapeutic, diagnostic, and bioinformatics data across Plus Therapeutics’ CNS oncology programs.
Fujifilm launches balloon-less EBUS bronchoscope
The EB-710US Ultrasound Bronchoscope is designed for pulmonary procedures and will be demonstrated at the American Thoracic Society Conference.
ACIST wins FDA clearance for Pro Diagnostic System
The Bracco company received U.S. clearance and launched ACIST Pro, a variable-rate contrast management system for image-guided cardiovascular procedures.
Braid Health launches $199 radiology second-opinion service
Patients can upload MRI, CT, X-ray, or ultrasound files and receive a written second opinion from a board-certified U.S. radiologist.
QT Imaging prices $10M raise for breast imaging platform
QT Imaging Holdings priced a $10M underwritten public offering of common stock and pre-funded warrants. The breast imaging technology company plans to use proceeds for working capital and general corporate purposes.
PSMA PET guidance anchors EDAP-Telix HIFU prostate work
EDAP TMS and Telix Pharmaceuticals signed a letter of intent to explore clinical research combining Focal One Robotic HIFU with Telix PSMA PET imaging agents in prostate cancer care.
UnitedHealthcare cites radiology costs in Maryland premium request
UnitedHealthcare is seeking an average 7.9% mid-year premium increase for some Maryland small-group plans. The insurer cited rising outpatient costs, including radiology, lab pathology, infusion, and radiation therapy.
Lumexa adds 4 imaging centers, including first UPMC JV site
Lumexa Imaging added 4 outpatient imaging centers across Pennsylvania, North Carolina, South Carolina, and Florida. The expansion includes acquired centers through joint ventures with UPMC and Advocate Health, plus 2 newly built locations.
PAI report finds 82% of U.S. physicians are now employed
A new PAI-Avalere report found that 82% of U.S. physicians are employed by hospitals, health systems, or corporate entities. Physician-owned settings now account for 18% of physicians and 36.1% of practices.