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