FDA-cleared K221564
Brainomix 360 e-ASPECTS
Brainomix Limited
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2023-02-23
Vendor
Brainomix Limited
7 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K231195
Brainomix 360 Triage ICH
Brainomix Limited
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-07-27
FDA-cleared K231837
Brainomix 360 Triage LVO
Brainomix Limited
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-09-28
FDA-cleared K232496
Brainomix 360 Triage Stroke
Brainomix Limited
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-11-21
FDA-cleared K242123
Brainomix 360 e-CTA
Brainomix Limited
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-06
FDA-cleared K243294
Brainomix 360 e-ASPECTS
Brainomix Limited
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2025-02-14
FDA-cleared K251983
Brainomix 360 Triage Stroke
Brainomix Limited
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2025-08-26