GeneralDevices & AI clearances

FDA 510(k) clearance for OOOPDS from Taiwan Main Orthopaedic Biotechnology

U.S. FDA2w ago

FDA cleared OOOPDS from Taiwan Main Orthopaedic Biotechnology through the 510(k) pathway; the radiology-category device is assigned product code LLZ.

  • Regulator/pathway: U.S. FDA, 510(k).
  • Device: OOOPDS; applicant: Taiwan Main Orthopaedic Biotechnology Co., Ltd.
  • Committee: Radiology; product code: LLZ.
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