Atlas FDA

SHO

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Parkinsonian Syndrome Diagnostic Aid
Device class
Class II (moderate risk)
Regulation
21 CFR 882.2000
Medical specialty
Neurology
FDA definition
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.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
neuropacs (DEN240071)Automated Imaging Diagnostics, LLC2026-04-03

Track SHO automatically

Every clearance here is in the API, with alerts when new ones post.