| Device |
parkinsonian syndrome diagnostic aid |
| 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. |
| Physical State |
Software that processes patient-specific data and returns classification results to aid in clinical diagnosis. The device may include software for pre-processing and reviewing the algorithmic inputs. |
| Technical Method |
Software analyzes patient-specific data to aid in diagnosis of patients with Parkinsonian symptoms. May use algorithmic approaches to produce an output indicative of a patient’s clinical diagnosis of Parkinson's disease or other Parkinsonian syndromes. |
| Target Area |
N/A |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | SHO |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.2000
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
