SHO — Parkinsonian Syndrome Diagnostic Aid Class II
FDA product code SHO covers "Parkinsonian Syndrome Diagnostic Aid", a Class II medical device regulated under 21 CFR 882.2000. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHO
- Device Class
- Class II
- Regulation Number
- 882.2000
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240071 | Automated Imaging Diagnostics | neuropacs | Apr 3, 2026 |