K253738
- 510(k) number
- K253738
- Device name
- 3.0T AIR 32CH HNA
- Applicant
- Ge Healthcare Coils (Usa Instruments, Inc.) OH · US
- Product code
- MOS — Coil, Magnetic Resonance, Specialty
- Decision date
- 2026-01-23
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253738.pdf
Official FDA record: K253738
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.