K253648
- 510(k) number
- K253648
- Device name
- Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-02-23
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253648.pdf
Official FDA record: K253648
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.