FDA Product Code QZL: Post-ablation Tissue Response Prediction Software
A Post-ablation Tissue Response Prediction Software Is An Image Processing Device Intended To Aid Physicians With Adjunctive Information In Their Clinical Assessment Of The Ablation Zone Following A Tissue Ablation Procedure. This Device Uses Information Extracted From Medical Images Along With Other Clinical Data To Predict The Ablation Zone Post Treatment.
Leading manufacturers include Techsomed Medical Technologies , Ltd..
FDA 510(k) Cleared Post-ablation Tissue Response Prediction Software Devices (Product Code QZL)
About Product Code QZL - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QZL since 2023, with 1 receiving FDA clearance (average review time: 178 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 QZL have taken an average of 88 days to reach a decision - down from 267 days historically, suggesting improved FDA processing for this classification.
QZL devices are reviewed by the Radiology panel. Browse all Radiology devices →