DEN240071
- 510(k) number
- DEN240071
- Device name
- neuropacs
- Applicant
- Automated Imaging Diagnostics, LLC FL · US
- Product code
- SHO — Parkinsonian Syndrome Diagnostic Aid
- Decision date
- 2026-04-03
- Date received
- 2024-12-04
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN240071
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.