K253614
- 510(k) number
- K253614
- Device name
- EchoNavigator R5.0
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-03-17
- Date received
- 2025-11-18
- 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: K253614.pdf
Official FDA record: K253614
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.