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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device embryo image assessment system, assisted reproduction
Definition The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .
Product CodePBH
Regulation Number 884.6195
Device Class 2


Premarket Reviews
ManufacturerDecision
AUXOGYN, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
VITROLIFE A/S
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1

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