17. Regulatory Landscape Quizzes

Regulatory Landscape Quizzes

Identifying Stakeholders

Who would be a stakeholder for a tool that does the following?

An algorithm that measures the change in the size of a lung nodule over time from consecutive chest x-rays.

SOLUTION:
  • Patient
  • FDA
  • Radiologist
  • Software developer
  • Hospital

FDA Risk Classes

QUIZ QUESTION::

Match the following algorithm descriptions to their appropriate FDA risk class.

ANSWER CHOICES:



Algorithm

Class

An algorithm that fully replaces the radiologist in diagnosing breast cancer.

An algorithm that draws a bounding box around suspicious areas of an image for interpretation by a radiologist.

An algorithm that segments the lungs and measures their volume for interpretation by a radiologist.

SOLUTION:

Algorithm

Class

An algorithm that draws a bounding box around suspicious areas of an image for interpretation by a radiologist.

An algorithm that segments the lungs and measures their volume for interpretation by a radiologist.

An algorithm that draws a bounding box around suspicious areas of an image for interpretation by a radiologist.

An algorithm that segments the lungs and measures their volume for interpretation by a radiologist.

An algorithm that fully replaces the radiologist in diagnosing breast cancer.