K253499
- 510(k) number
- K253499
- Device name
- Ascent3T Neonatal Magnetic Resonance Imaging System
- Applicant
- Eyas Medical Imaging, Inc. OH · US
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-01-26
- Date received
- 2025-10-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K253499.pdf
Official FDA record: K253499
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.