K260519
- 510(k) number
- K260519
- Device name
- Smart Fit TorsoCardiac 1.5T
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd. CN
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2026-03-20
- Date received
- 2026-02-17
- 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: K260519.pdf
Official FDA record: K260519
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.