K253780
- 510(k) number
- K253780
- Device name
- SIGNA Bolt
- Applicant
- Ge Medical Systems, LLC WI · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-02-06
- Date received
- 2025-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253780.pdf
Official FDA record: K253780
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.