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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radiological image processing software for radiation therapy
Definition To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.
Product CodeQKB
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
DEEPVOXEL INC
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDMIND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIM SOFTWARE INC.
  SUBSTANTIALLY EQUIVALENT 3
MIRADA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MVISION AI
  SUBSTANTIALLY EQUIVALENT 1
QUANTITATIVE RADIOLOGY SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
THERAPANACEA
  SUBSTANTIALLY EQUIVALENT 2
VYSIONEER INC.
  SUBSTANTIALLY EQUIVALENT 3
XIAMEN MANTEIA TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1

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