K233728
- 510(k) number
- K233728
- Device name
- SIGNA Champion
- Applicant
- Ge Healthcare (Tianjin) Company Limited CN
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-01-19
- Date received
- 2023-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233728.pdf
Official FDA record: K233728
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.