K262330
- 510(k) number
- K262330
- Device name
- dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2026-07-30
- Date received
- 2026-07-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K262330.pdf
Official FDA record: K262330
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.