K251397
- 510(k) number
- K251397
- Device name
- Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-06-04
- Date received
- 2025-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251397.pdf
Official FDA record: K251397
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.