FDA Product Code QDG: Parathyroid Autofluorescence Imaging Device
An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis.
Leading manufacturers include Fluoptics Sas (A Getinge Group Company), Fluoptics Sas and Dendrite Imaging, Inc..
FDA 510(k) Cleared Parathyroid Autofluorescence Imaging Device Devices (Product Code QDG)
About Product Code QDG - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QDG since 2018, with 5 receiving FDA clearance (average review time: 118 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under QDG have taken an average of 59 days to reach a decision - down from 148 days historically, suggesting improved FDA processing for this classification.
QDG devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →