FDA Product Code QTZ: Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
To Provide Radiological Image Processing Tools For Planning, Monitoring, And Evaluating Ablation Therapy.
Leading manufacturers include Mim Software, Inc., Eigen and Techsomed.
FDA 510(k) Cleared Radiological Image Processing Software For Ablation Therapy Planning And Evaluation Devices (Product Code QTZ)
About Product Code QTZ - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QTZ since 2022, with 7 receiving FDA clearance (average review time: 221 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under QTZ have taken an average of 107 days to reach a decision - down from 267 days historically, suggesting improved FDA processing for this classification.
QTZ devices are reviewed by the Radiology panel. Browse all Radiology devices →