FDA Product Code QQE: Image Management Software For Planning Of Otologic And Neurotologic Procedures
Display, Segmentation, And Transfer Of Medical Image Data From Medical Imaging Systems For Planning Of Otological And Neurotological Procedures.
Leading manufacturers include Cascination AG.
FDA 510(k) Cleared Image Management Software For Planning Of Otologic And Neurotologic Procedures Devices (Product Code QQE)
About Product Code QQE - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QQE since 2021, with 3 receiving FDA clearance (average review time: 225 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QQE have taken an average of 266 days to reach a decision - up from 204 days historically. Manufacturers should account for longer review timelines in current project planning.
QQE devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →