K250800
- 510(k) number
- K250800
- Device name
- UroNav 4
- Applicant
- Philips DS North America, LLC FL · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-06-05
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K250800.pdf
Official FDA record: K250800
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.