# K252992: CT Rembra RT; CT Areta RT; CT Rembra

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Mar 23, 2026 after 186 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K930090 (1993). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232491: CT 5300, Philips Healthcare (Suzhou) Co., Ltd. (2024) Summary page 5.
- K171850: Philips CT Big Bore, Philips Medical Systems (Cleveland), Inc. (2017) Summary page 6.
- K240844: Spectral CT 7500 RT, Philips Medical Systems Technologies, Ltd. (2024) Summary page 6.

## Indications for use
The proposed CT Rembra RT, CT Areta RT, and CT Rembra are Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment support, components and accessories. The system is indicated for diagnostic imaging in radiology, head and whole-body X-ray Computed Tomography applications in oncology as part of treatment preparation and radiation therapy planning, vascular, interventional, neurology and cardiology, for patients of all ages. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or a professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Source page: https://510kreport.com/device/K252992
Methodology: https://510kreport.com/methodology