GeneralDevices & AI clearances

Fujifilm APERTO Lucent MRI System Gains FDA 510(k) Clearance

U.S. FDA1w ago

FDA cleared Fujifilm's APERTO Lucent MRI system via the 510(k) pathway; the device is listed under the radiology panel with product code LNH.

  • Regulator: U.S. FDA; pathway: 510(k); applicant: Fujifilm Corporation.
  • Device classified under the radiology committee, product code LNH.
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