FDA-cleared K260406
Brainomix 360 Hyperdensity
Brainomix Limited
Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2026-06-12
Vendor
Brainomix Limited
8 FDA-cleared listings in this directory.
Claim vendor profile FDA-cleared K251983
Brainomix 360 Triage Stroke
Brainomix Limited
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
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...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-02-14
FDA-cleared K242123
Brainomix 360 e-CTA
Brainomix Limited
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...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-01-06
FDA-cleared K232496
Brainomix 360 Triage Stroke
Brainomix Limited
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...
- 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
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...
- 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
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...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-07-27
FDA-cleared K221564
Brainomix 360 e-ASPECTS
Brainomix Limited
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities...
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-02-23