K233853
- 510(k) number
- K233853
- Device name
- LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2024-03-14
- Date received
- 2023-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K233853.pdf
Official FDA record: K233853
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.