De Novo Classifications

FDA submissions for De Novo Classifications in the General, Plastic Surgery (SU) review panel, including product codes and regulations.

Section range: §§ 878.1830–878.1840

CFR Part: 878

Product Codes

Product CodeDevice NameRegulationClassDevices
QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer878.183021
SHYSoftware-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.878.184021
Innolitics

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