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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeSHO
Regulation Number 882.2000
Device Class 2


Premarket Reviews
ManufacturerDecision
AUTOMATED IMAGING DIAGNOSTICS, LLC
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