K252379
- 510(k) number
- K252379
- Device name
- AIR Recon DL
- Applicant
- Ge Medical Systems, LLC WI · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-12-23
- Date received
- 2025-07-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252379.pdf
Official FDA record: K252379
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.