K251808
- 510(k) number
- K251808
- Device name
- Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-07-11
- Date received
- 2025-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251808.pdf
Official FDA record: K251808
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.