Chapter 8. Artificial Intelligence-based Software
118 Regulatory Affairs Professionals Society (RAPS)
Figure 8-2. A Brief Chronology of Computer-Assisted Device Evolution
Jun 1998
M1000 Image Checker from Hologic is the
first CADe SaMD approved by the FDA
for mammography via PMA (P970058)25
1998-2007
FDA approves several PMAs for dental, chest,
mammography, and ultrasound indications26
Jan 2018
IDx-DR from IDx is the first autonomous
software to evaluate ophthalmic images for
diagnostic screening cleared via a De Novo
Classification Request (DEN180001)28
May 2018
OsteoDetect from Imagen Technologies
is the first CADe/x cleared via a De Novo
Classification Request (DEN180005)30
Feb 2020
FDA issues a final order to reclassify medical
image analyzers and associated software
from class III (premarket approval) to class II
(premarket notification with special controls)32
Jul 2017
QuantX from Quantitative Insights is the
first CADx cleared by FDA via a De Novo
Classification Request (DEN170022)27
Feb 2018
ContaCT from Viz.AI is the first CADt
cleared via a De Novo Classification
Request (DEN170073)29
Aug 2019
Caption Guidance from Bay Labs is
the first radiological CADa/o guidance
system cleared via a De Novo
Classification Request (DEN190040)31
Feb 2023
The first radiological machine learning-
based quantitative imaging software
with predetermined change control plan
is cleared via a De Novo Classification
Request (DEN220063)33
CADa/o, computer-assisted acquisition and/or optimization CADe, computer-assisted detection CADx, computer-assisted diagnosis
FDA, Food and Drug Administration PMA, premarket approval SaMD, Software as a medical device
Created by Gopal Abbineni and Hortense Allison