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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diagnostic software, k-nearest neighbor algorithm, autoimmune disease
Definition The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.
Product CodeNVI
Regulation Number 862.3100
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aneurysm 1 1
Stenosis 1 1
Vascular Dissection 1 1

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