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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device image management software for planning of otologic and neurotologic procedures
Regulation Description Medical image management and processing system.
Definition Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
Product CodeQQE
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
CASCINATION AG
  SUBSTANTIALLY EQUIVALENT 3

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