SHOClass II
Parkinsonian Syndrome Diagnostic Aid
21 CFR 882.2000 / Neurology
SHO is the FDA product code for Parkinsonian Syndrome Diagnostic Aid, a class II device type, regulated under 21 CFR 882.2000. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SHO
- Device name
- Parkinsonian Syndrome Diagnostic Aid
- 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.
- Regulation
- 21 CFR 882.2000
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SHO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code SHO| Applicant | Clearances |
|---|---|
| Automated Imaging Diagnostics, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code SHO.
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