QZL — Post-Ablation Tissue Response Prediction Software Class II

FDA Device Classification

Classification Details

Product Code
QZL
Device Class
Class II
Regulation Number
892.2052
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243084techsomed medical technologiesBioTraceIO Precision (2.0)December 27, 2024
DEN230020techsomed medical technologiesBioTraceIO LiteDecember 22, 2023