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GeneralDevice clearance

FDA Clears FUJIFILM Synapse PACS 7.6.0

FDA 510(k) — Radiology devices2w ago

FDA cleared FUJIFILM's Synapse PACS 7.6.0, a picture archiving and communication system for radiology (product code QIH).

  • Manufacturer: FUJIFILM Healthcare Americas Corporation; 510(k) clearance for software version 7.6.0.
  • No new clinical performance data or predicate device information reported in the clearance notice.
  • Clearance via the 510(k) pathway; product code QIH.
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