De Novo Classifications

FDA submissions for De Novo Classifications in the Radiology (RA) review panel, including product codes and regulations.

Section range: §§ 892.8200–892.8500

CFR Part: 892

Product Codes

Product CodeDevice NameRegulationClassDevices
SHERadiological Software System For Delivery Date Prediction892.820021
SEZRadiological Software Device To Predict Future Breast Cancer Risk892.850021
Innolitics

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