QZL

Post-Ablation Tissue Response Prediction Software

Product code
QZL
Device name
Post-Ablation Tissue Response Prediction Software
Device class
Class 2
21 CFR
21 CFR 892.2052
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-12-27.

NumberDecision dateApplicantDevice nameSummary
K2430842024-12-27Techsomed Medical Technologies , Ltd.BioTraceIO Precision (2.0)PDF
DEN2300202023-12-22Techsomed Medical Technologies , Ltd.BioTraceIO Lite

1 summaries are archived here for direct download.

Official FDA classification page: QZL
Classification and pathway per current FDA publications. Data from openFDA (CC0).