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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prostate lesion, documentation, system
Definition Produces an elasticity image of the prostate to document prostate abnormalities that were previously identified by digital rectal examination.
Product CodeOQT
Regulation Number 876.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTANN LABORATORIES, INC
  GRANTED 1

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