510(k) DEN240071

neuropacs by Automated Imaging Diagnostics, LLC — Product Code SHO

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 3, 2026
Date Received: December 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.