K252992
- 510(k) number
- K252992
- Device name
- CT Rembra RT; CT Areta RT; CT Rembra
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd. CN
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2026-03-23
- Date received
- 2025-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252992.pdf
Official FDA record: K252992
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.