510(k) DEN240071
- Device
- neuropacs
- Applicant
- Automated Imaging Diagnostics, LLC
- 510(k) number
- DEN240071
- Product code
- SHO
- Decision
- Unknown (DENG)
- Decision date
- 2026-04-03
- Date received
- 2024-12-04
- Regulation
- 882.2000
- Classification name
- Parkinsonian Syndrome Diagnostic Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- David Vaillancourt
- Address
- 9706 SW 34th Ln. Gainesville FL US 32608 32608
Source Documents
510(k) summary PDF not indicated by FDA