FDA-cleared K250248

BriefCase-Triage

Aidoc Medical, Ltd.

Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.

Modality
CT/CTA
Anatomy
Chest and lungs
Decision
2025-02-14
FDA-cleared K233968

CINA-iPE

Avicenna.AI

Worklist triage and notification for suspected incidental pulmonary embolism on contrast-enhanced CT acquired for another indication; not a diagnostic device

Modality
CT/CTA
Anatomy
Lung and pulmonary arterial segments containing incidental pulmonary embolism; subsegmental arteries are out of scope
Decision
2024-03-13
FDA-cleared K232751

BriefCase-Triage

Aidoc Medical, Ltd.

Case-level triage and notification of suspected central pulmonary embolism on CTPA in adults or transitional adolescents aged 18 years and older, in parallel with standard-of-care...

Modality
CT/CTA
Anatomy
Chest and central pulmonary arteries
Decision
2023-10-30
FDA-cleared K213886

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-04-26
FDA-cleared K210237

CINA CHEST

Avicenna.AI

Radiological computer-aided triage and notification for chest CTA suspected pulmonary embolism and chest or thoraco-abdominal CTA suspected aortic dissection, assisting hospital...

Modality
CT/CTA
Anatomy
Chest and thoraco-abdominal aorta
Decision
2021-05-19
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