FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Embrace Neonatal MRI System
K Number: K254277
·
Decision Mar 13, 2026
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
5
Review Days
73
Basic Information
- Device Name
- Embrace Neonatal MRI System
- K Number
- K254277
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aspect Imaging, Ltd.
- Date Received
- December 30, 2025
- Decision Date
- March 13, 2026
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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