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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, medical image
Definition For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
Product CodeMYN
Regulation Number 892.2070
Device Class 2


Premarket Reviews
ManufacturerDecision
DEEPTEK MEDICAL IMAGING PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
DENTI.AI TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMAGEN TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 4
IMIDEX INC.
  SUBSTANTIALLY EQUIVALENT 1
NOBEL BIOCARE AB
  SUBSTANTIALLY EQUIVALENT 1
OVERJET INC.
  SUBSTANTIALLY EQUIVALENT 1
OVERJET, INC
  SUBSTANTIALLY EQUIVALENT 2
OVERJET, INC.
  SUBSTANTIALLY EQUIVALENT 2
PEARL INC.
  SUBSTANTIALLY EQUIVALENT 1
QURE.AI TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIDEAHEALTH, INC
  SUBSTANTIALLY EQUIVALENT 1
VIDEAHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 0 0 0 0 0

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