Table 1 Summary of four regulatory approved software packages and associated features

CE/FDA status

CE Mark and FDA 510(k)

CE Mark and FDA 510(k)

FDA 510(k)

FDA 510(k)

Imaging requirements

PET, optional MRI or CT

PET, optional MR or CT

PET, optional MRI or CT

PET, optional MRI or CT

Normative database

54 controls

25 controls

80 controls [48]

 > 100 controls

QC procedure

Visual QC for registration quality

Partial volume correction

Not performed

Spatial normalisation

Standard space (MNI)

Attenuation correction

Required for image acquisition and processing

Reference regions

Customizable e.g. pons, whole cerebellum, cerebellar cortex

Pons, whole cerebellum

Pons, whole cerebellum, cerebellar cortex

Pons, whole cerebellum, cerebellar cortex

Target regions available in addition to harmonised mask

Customizable e.g. Left/right hemisphere for: anterior cingulate gyrus, inferior medial frontal gyrus, lateral temporal lobe, posterior cingulate gyrus, precuneus, and superior parietal lobule

Left/right hemisphere for all (except midbrain and vermis): frontal cortex, sensorimotor cortex, broca’s region, anterior cingulate, posterior cingulate, caudate nucleus, lentiform nucleus, thalamus, parietal cortex, parietotemporal cortex, lateral temporal cortex, medial temporal cortex, primary visual cortex, associative visual cortex, midbrain, and vermis

Left/right hemisphere for all: frontal cortex, anterior cingulate, occipital cortex parietal cortex, lateral temporal cortex, precuneus/posterior cingulate,

Left/right hemisphere for all: Prefrontal, anterior cingulate, precuneus/posterior cingulate, parietal, lateral/mesial temporal, occipital, sensorimotor

Metrics reported

SUVr, z-score, Centiloid*

SUVr, z-score

SUVr, z-score

SUVr, z-score