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FDA-cleared K233247

Heuron ICH

Heuron Co., Ltd.

Authorized purpose: Triage and notification of suspected intracranial hemorrhage on non-contrast head CT in adults and transitional adolescents aged 18 years and older, to assist prioritization while full images remain subject to standard-of-care interpretation.

Modality
CT/CTA
Anatomy
Head/brain
Decision
2024-05-15
FDA-cleared K231642

Veuron-Brain-pAb3

Heuron Co., Ltd.

Authorized purpose: Registration, fusion, display, and quantitative SUVR analysis of brain amyloid PET with MRI support to aid clinician assessment; outputs are reference information, not a stand-alone dementia diagnosis.

Modality
MRI
Anatomy
Brain
Decision
2023-10-13