De Novo · Granted
Grantedneuropacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Automated Imaging Diagnostics, LLC · SHO Parkinsonian Syndrome Diagnostic Aid
Granted on Apr 3, 2026 as a new device type through De Novo after a 485-day review.
- Decided
- Apr 3, 2026
- Review
- 485 days
- Class
- Class II
- Product code
- SHO
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SHO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SHO devicesSHO Parkinsonian Syndrome Diagnostic Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHO
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHO
Too few SHO 510(k)s in any year since 2007 to give a median.
Recalls per year · SHO
No recall names SHO since 2007.
Adverse event reports per year · SHO
No MAUDE report names SHO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (160 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240071 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240071: neuropacs.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240071
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026