510(k) K261758
K261758 is an FDA 510(k) premarket notification submitted by Aspect Imaging, Ltd. for the device "Embrace Vision Neonatal MRI System". The FDA issued a decision of Substantially Equivalent on September 16, 2026. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Aspect Imaging, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2026
- Date Received
- May 28, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type