FDA-cleared K203508

BriefCase

Aidoc Medical, Ltd.

BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel...

Modality
CT/CTA
Anatomy
Adult head, brain, cervical spine, pulmonary arteries, and thorax
Decision
2020-12-29
FDA-cleared K201103

Xeleris V Processing and Review Systems

GE Healthcare

Xeleris V is intended for nuclear-medicine or radiology practitioners and referring physicians to display, process, archive, print, report, and network nuclear-medicine data from...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole-body, lung, brain/striatum, and other anatomy represented in nuclear-medicine, PET, CT, and MR studies
Decision
2020-09-25
FDA-cleared K201020

BriefCase

Aidoc Medical, Ltd.

BriefCase analyzes contrast-enhanced chest CT for suspected pulmonary embolism and notifies or prioritizes the study in the labeled hospital or cloud worklist workflow; the output...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-08-26