510(k) DEN240071
DEN240071 is an FDA 510(k) premarket notification submitted by Automated Imaging Diagnostics, LLC for the device "neuropacs". The FDA issued a decision of De Novo Granted on Apr 3, 2026. The device falls under product code SHO (Parkinsonian Syndrome Diagnostic Aid), a Class II device regulated under 21 CFR 882.2000.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Apr 3, 2026
- Date Received
- Dec 4, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Parkinsonian Syndrome Diagnostic Aid
- Device Class
- Class II
- Regulation Number
- 882.2000
- Review Panel
- NE
- Submission Type
A Parkinsonian syndrome diagnostic aid is a prescription device that analyzes patient-specific data to aid in the diagnosis of Parkinsonian syndromes. This device is intended for adjunctive use and not intended as a stand-alone diagnostic.