# DEN240071: neuropacs

- Pathway: De Novo (Direct)
- Applicant: Automated Imaging Diagnostics, LLC
- Decided: Apr 3, 2026 after 485 days
- Product code: SHO (Parkinsonian Syndrome Diagnostic Aid)
- Device class: 2
- Regulation: 21 CFR 882.2000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The neuropacs™ system is a software application intended to receive and analyze diffusion MRI data from patients aged 40 years and older with either Parkinson's Disease (PD), Multiple System Atrophy Parkinsonian variant (MSAp), or Progressive Supranuclear Palsy (PSP). The neuropacs™ system provides a classification report based on degenerative brain patterns of MSAp and PSP, to help neuroradiologists and/or neurologists in differentiating these diseases from PD. The neuropacs™ system is intended to provide supplemental information in conjunction with a standard neurological assessment and other clinical tests. This device does not rule out other potential causes of Parkinsonism symptoms or signs and is intended to be used after all other potential causes of Parkinsonism symptoms (such as dementia with Lewy bodies, vascular Parkinsonism, drug-induced Parkinsonism, and corticobasal degeneration/syndrome) have been ruled out by trained clinicians on the basis of clinical, neurological, and other laboratory tests. Patient management decisions should not be made solely on the basis of analysis by the neuropacs™ system.

Source page: https://510kreport.com/device/DEN240071
Methodology: https://510kreport.com/methodology