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FDA-cleared K241719

NeuroICH

Neurocareai Inc.

Authorized purpose: Notify hospital-network clinicians and neurovascular or neurosurgical specialists of suspected ICH on acute non-contrast head CT in parallel with standard-of-care interpretation; it is not a diagnostic device.

Modality
CT/CTA
Anatomy
Brain, with intracranial hemorrhage (ICH) subtypes including extradural, subdural, subarachnoid, intraparenchymal, and intraventricular hemorrhage.
Decision
2024-11-07