DeviceClearance

Product code SHO— Neurology

neuropacs

Classification name
Parkinsonian Syndrome Diagnostic Aid
Device class
Class 2
Regulation
21 CFR 882.2000
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SHO under 21 CFR 882.2000, via openFDA

Market context for product code SHO

FDA has cleared 1 device under product code SHO, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SHO

Recent clearances under product code SHO

Data sourced from openFDA. This site is unofficial and independent of the FDA.