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FDA-cleared K260406

Brainomix 360 Hyperdensity

Brainomix Limited

Authorized purpose: Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.

Modality
CT/CTA
Anatomy
Brain
Decision
2026-06-12
FDA-cleared K251983

Brainomix 360 Triage Stroke

Brainomix Limited

Authorized purpose: Triage and notification of suspected intracranial hemorrhage or anterior-circulation LVO on acute non-contrast head CT; not primary diagnosis.

Modality
CT/CTA
Anatomy
Brain/head, including intracranial ICA and M1 for LVO and intracranial hemorrhage findings
Decision
2025-08-26
FDA-cleared K243294

Brainomix 360 e-ASPECTS

Brainomix Limited

Authorized purpose: Brainomix 360 e-ASPECTS registers adult non-contrast brain CT, segments ASPECTS regions, and provides an editable ASPECTS score with highlighted regions and voxel contribution views to assist trained clinicians evaluating suspected ischemic stroke within 24 hours of last known well.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-02-14
FDA-cleared K242123

Brainomix 360 e-CTA

Brainomix Limited

Authorized purpose: Brainomix 360 e-CTA analyzes adult CTA brain DICOM for vessel visualization and post-processing, including MCA vessel-density asymmetry, contrast/phase context, overlays, and MIP views, for trained clinical review; it is not for mobile diagnosis and its vessel-density asymmetry ratio is limited to the MCA region.

Modality
CT/CTA
Anatomy
Brain
Decision
2025-01-06
FDA-cleared K232496

Brainomix 360 Triage Stroke

Brainomix Limited

Authorized purpose: Analyze non-contrast head CT images to help hospital networks and trained clinicians triage and prioritize suspected positive findings for intracranial ICA/M1 large-vessel occlusion and intracranial hemorrhage in adults in the acute setting within 24 hours of symptom onset or, when unclear, since last known well; the device is not a primary diagnostic device or rule-out device.

Modality
CT/CTA
Anatomy
Head/brain; intracranial ICA and M1 for LVO and intracranial hemorrhage
Decision
2023-11-21
FDA-cleared K231837

Brainomix 360 Triage LVO

Brainomix Limited

Authorized purpose: Notification-only, parallel triage of acute-setting brain CTA studies for suspected large-vessel occlusion (LVO), communicating cases to a neurovascular specialist for review; not diagnostic.

Modality
CT/CTA
Anatomy
Brain/head vasculature, specifically terminal ICA and MCA-M1
Decision
2023-09-28
FDA-cleared K231195

Brainomix 360 Triage ICH

Brainomix Limited

Authorized purpose: Provide notification-only parallel workflow triage of adult non-contrast brain CT studies acquired in the acute setting within 24 hours of symptom onset or since last known well when onset is unclear, notifying a specialist when intracranial hemorrhage is suspected.

Modality
CT/CTA
Anatomy
Brain
Decision
2023-07-27
FDA-cleared K221564

Brainomix 360 e-ASPECTS

Brainomix Limited

Authorized purpose: Assists clinician assessment of brain abnormalities and ischemic injury by generating an automated ASPECTS score for known MCA/ICA occlusion cases.

Modality
CT/CTA
Anatomy
Brain
Decision
2023-02-23