K260169
- 510(k) number
- K260169
- Device name
- AV Cardiac CT
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2026-03-05
- Date received
- 2026-01-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K260169.pdf
Official FDA record: K260169
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.