K250648
- 510(k) number
- K250648
- Device name
- Philips iCT CT system
- Applicant
- Philips Medical Systems Nederland B.V. IL
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-06-27
- Date received
- 2025-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250648.pdf
Official FDA record: K250648
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.