K252645
- 510(k) number
- K252645
- Device name
- LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2025-10-24
- Date received
- 2025-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252645.pdf
Official FDA record: K252645
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.