Body / AbdominalDevices & AI clearances

FDA Clears InkSpace Imaging's Small Body Array MRI Coil

U.S. FDAOct 5

FDA 510(k) clearance for InkSpace Imaging's Small Body Array (SBA12PH15x) MRI coil, a flexible body coil for magnetic resonance imaging.

  • Cleared via FDA 510(k) pathway under product code MOS (specialty MRI coil).
  • Manufactured by Inkspace Imaging, Inc., intended for body MRI.
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