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.
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| Record | Firm | Date |
|---|---|---|
| neuropacs (DEN240071) | Automated Imaging Diagnostics, LLC | 2026-04-03 |
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