GeneralDevices & AI clearances

FDA Clears IMGFAX Handheld Ultrasound Scanner

U.S. FDA2w ago

IMGFAX Co., Ltd. received FDA 510(k) clearance for its handheld ultrasound scanner, a general-purpose diagnostic imaging device.

  • Cleared through the 510(k) pathway under product code IYN (general-purpose diagnostic ultrasound).
  • The clearance was issued by the FDA's Radiology committee.
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