Avicenna.AI radiology AI products

FDA-cleared K240942

CINA-CSpine

Avicenna.AI

Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization;...

Modality: CT/CTA
Anatomy: Cervical spine; acute cervical-spine fractures including non-displaced lines and displaced fragments
Decision: 2024-09-12

FDA-cleared K240612

CINA-VCF

Avicenna.AI

Parallel worklist triage for suspected vertebral compression fractures in patients aged 50 years and over within the standard-of-care bone-health setting; not a diagnostic device

Modality: CT/CTA
Anatomy: Thoracic and lumbar vertebrae T1-L5 within chest and/or abdomen CT
Decision: 2024-05-31

MSK and bone Acute triage and notification

FDA-cleared K233342

CINA-ASPECTS

Avicenna.AI

CADx assistance for assessment and characterization of brain tissue abnormalities and early ischemic injury in patients with known MCA or ICA occlusion, using ASPECTS regions and...

Modality: CT/CTA
Anatomy: Brain, including ASPECTS regions
Decision: 2024-03-15

Detection and CADe

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

Pulmonary embolism Quantification and segmentation Acute triage and notification

FDA-cleared K221716

CINA

AVICENNA.AI

CINA analyzes non-enhanced head CT and head CTA DICOM in parallel with standard interpretation to flag suspected intracranial hemorrhage and anterior-circulation large-vessel...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-11-22

Stroke and ICH triage Acute triage and notification

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

Pulmonary embolism Detection and CADe Acute triage and notification

FDA-cleared K200855

CINA

AVICENNA.AI

CINA analyzes nonenhanced head CT for suspected intracranial hemorrhage and head CTA for suspected large-vessel occlusion for computer-aided triage and notification in parallel...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-06-24

Stroke and ICH triage Detection and CADe Acute triage and notification