Musculoskeletal (MSK)Devices & AI clearances

Velmeni V4D 3D Dental Imaging System Receives FDA Clearance

U.S. FDA1w ago

FDA cleared VELMENI for DENTISTS (V4D) 3D, a dental digital imaging system from Velmeni, Inc., via 510(k) pathway (product code QIH).

  • FDA clearance via 510(k) premarket notification.
  • Device: VELMENI for DENTISTS (V4D) 3D; manufacturer: Velmeni, Inc.
  • Product code QIH, reviewed by the Radiology panel.
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