K253670
- 510(k) number
- K253670
- Device name
- SmartCT (R3.0 (L10))
- Applicant
- Philips Medical Systems B.V. NL
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-07-10
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253670.pdf
Official FDA record: K253670
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.