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FDA-cleared K240942

CINA-CSpine

Avicenna.AI

Authorized purpose: Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization; it is not designed to detect vertebral compression fractures.

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

Authorized purpose: 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
FDA-cleared K233342

CINA-ASPECTS

Avicenna.AI

Authorized purpose: 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 scoring to evaluate extent of disease during image interpretation.

Modality
CT/CTA
Anatomy
Brain, including ASPECTS regions
Decision
2024-03-15
FDA-cleared K233968

CINA-iPE

Avicenna.AI

Authorized purpose: 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 K221716

CINA

AVICENNA.AI

Authorized purpose: 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 occlusion (distal ICA, MCA-M1 or proximal MCA-M2), issuing worklist and active notifications with informational previews for trained-radiologist triage; it does not diagnose or alter original images.

Modality
CT/CTA
Anatomy
Brain
Decision
2022-11-22
FDA-cleared K210237

CINA CHEST

Avicenna.AI

Authorized purpose: Radiological computer-aided triage and notification for chest CTA suspected pulmonary embolism and chest or thoraco-abdominal CTA suspected aortic dissection, assisting hospital networks and trained radiologists with workflow prioritization in parallel with standard-of-care interpretation.

Modality
CT/CTA
Anatomy
Chest and thoraco-abdominal aorta
Decision
2021-05-19
FDA-cleared K200855

CINA

AVICENNA.AI

Authorized purpose: 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 with standard care; the output is not a primary diagnosis.

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