GeneralDevices & AI clearances

FDA Clears NeuroLogica's BodyTom Elite Portable CT Scanner

U.S. FDA2w ago

FDA 510(k) clearance for the BodyTom Elite (NL4000) mobile full-body CT scanner from NeuroLogica Corp., a Samsung subsidiary. Product code JAK.

  • NeuroLogica Corp., a Samsung company, received clearance for the BodyTom Elite CT scanner.
  • The device is classified as a computed tomography system (product code JAK) under the FDA's radiology panel.
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