K254190
- 510(k) number
- K254190
- Device name
- dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2026-01-14
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K254190.pdf
Official FDA record: K254190
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.