Embrace Vision Neonatal MRI System— 510(k) K261758
Substantially EquivalentAspect Imaging, Ltd.
FDA 510(k) clearance K261758 for Embrace Vision Neonatal MRI System, Substantially Equivalent on 2026-09-16. Applicant: Aspect Imaging, Ltd.. Device class: 2.
Summary
Embrace Vision Neonatal MRI System comes from Aspect Imaging, Ltd. under product code LNH (System, Nuclear Magnetic Resonance Imaging). The record doesn't describe the system beyond its name and code.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Aspect Imaging filed from Shoham, Israel. The decision came 111 calendar days after receipt (May 28 to September 16, 2026).
Clearance details
- Applicant
- Aspect Imaging, Ltd.
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shoham, IL
Recent devices under product code LNH
view allMore clearances from Aspect Imaging, Ltd.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.