From X-Rays to AI: Navigating US Regulations in Radiological Health
119
from Picture Archiving and Communications
Systems to Medical Image Management and
Processing Systems and excluded software
functions for the storage and display of medical
images from the definition. MIMPS currently
only includes software components that provide
advanced or complex image processing func-
tions for image manipulation enhancement, or
quantification that are intended for use in the
interpretation and analysis of medical images.
These devices are regulated as Class II medical
devices via a 510(k) notification pathway.
AI/ ML devices classified as MIMPS
should follow the the Digital Imaging and
Communication in Medicine (DICOM) stan-
dard. The DICOM standard has evolved as the
primary format for medical images in clinical
use. In addition, the American Association of
Physicists in Medicine (AAPM) Report 270
and the Report of Task Group (TG) 18 define
Figure 8-3. Schematic Representation of Number of Computer-Assisted Detection Clearances
by (a) FDA Category and (b) by Year Cleared According to Data From the American College of
Radiology’s Data Science Institute – AI Central
(a)
(b)
Year
CADe, computer-assisted detection CADe/x, computer-assisted detection/diagnosis CADt, computer-assisted triage CADx, computer-
assisted diagnosis MIMPS, Medical image management and processing system
Source: ACR Data Science Institute AI Central
CADe
(n)
119
from Picture Archiving and Communications
Systems to Medical Image Management and
Processing Systems and excluded software
functions for the storage and display of medical
images from the definition. MIMPS currently
only includes software components that provide
advanced or complex image processing func-
tions for image manipulation enhancement, or
quantification that are intended for use in the
interpretation and analysis of medical images.
These devices are regulated as Class II medical
devices via a 510(k) notification pathway.
AI/ ML devices classified as MIMPS
should follow the the Digital Imaging and
Communication in Medicine (DICOM) stan-
dard. The DICOM standard has evolved as the
primary format for medical images in clinical
use. In addition, the American Association of
Physicists in Medicine (AAPM) Report 270
and the Report of Task Group (TG) 18 define
Figure 8-3. Schematic Representation of Number of Computer-Assisted Detection Clearances
by (a) FDA Category and (b) by Year Cleared According to Data From the American College of
Radiology’s Data Science Institute – AI Central
(a)
(b)
Year
CADe, computer-assisted detection CADe/x, computer-assisted detection/diagnosis CADt, computer-assisted triage CADx, computer-
assisted diagnosis MIMPS, Medical image management and processing system
Source: ACR Data Science Institute AI Central
CADe
(n)