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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device x-ray, computed tomography, cone-beam
Regulation Description Computed tomography x-ray system.
Definition Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.
Product CodeSFV
Regulation Number 892.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
PLANMED OY
  SUBSTANTIALLY EQUIVALENT 1

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