510(k) clearance
Embrace Vision Neonatal MRI System
- 510(k) number
- K261758
- Applicant
- Aspect Imaging, Ltd.
- Decision date
- Sep 16, 2026
- Date received
- May 28, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LNH
- Device type
- System, Nuclear Magnetic Resonance Imaging
- Device class
- Class II
- Regulation
- 21 CFR 892.1000
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shoham, IL