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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computer-assisted diagnostic software for lesions suspicious for cancer
Regulation Description Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
Definition Assist users in characterizing lesions identified on acquired medical images
Product CodePOK
Regulation Number 892.2060
Device Class 2


Premarket Reviews
ManufacturerDecision
AISAP
  SUBSTANTIALLY EQUIVALENT 1
AVENDA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVICENNA.AI
  SUBSTANTIALLY EQUIVALENT 1
BRAINOMIX LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTHEART
  SUBSTANTIALLY EQUIVALENT 3
CIRCLE CARDIOVASCULAR IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ECHO IQ, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ISCHEMAVIEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOIOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
OPTELLUM, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION MEDICAL VENTURES, INC. DBA REVEALDX
  SUBSTANTIALLY EQUIVALENT 1
SONIO
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Image Display Error/Artifact 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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