Interventional (IR)CardiacDevices & AI clearances

Fujifilm SCENARIA View Phase 6.0 Cleared by FDA

U.S. FDA1w ago

FDA cleared Fujifilm's SCENARIA View Phase 6.0 x-ray angiographic system via the 510(k) pathway (product code JAK).

  • Device falls under product code JAK, indicating a Class II x-ray angiographic system.
  • Clearance holder is Fujifilm Corporation.
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