K253808
- 510(k) number
- K253808
- Device name
- AIR Recon DL
- Applicant
- GE Medical Systems WI · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-08-13
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253808.pdf
Official FDA record: K253808
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.