PediatricGeneralDevices & AI clearances

FDA Clears Aspect Imaging's Embrace Vision Neonatal MRI

U.S. FDA1w ago

FDA cleared the Embrace Vision Neonatal MRI System (Aspect Imaging) via 510(k) pathway for neonatal MRI imaging. Product code LNH, radiology panel.

  • The Embrace Vision Neonatal MRI System is designed for MRI imaging of neonates.
  • Clearance was granted through the 510(k) substantial equivalence pathway.
  • The device is classified under product code LNH and reviewed by the radiology panel.
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