K254277
- 510(k) number
- K254277
- Device name
- Embrace Neonatal MRI System
- Applicant
- Aspect Imaging, Ltd. IL
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-03-13
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K254277.pdf
Official FDA record: K254277
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.