DeviceClearance

Product code QZL— Radiology

BioTraceIO Lite

Classification name
Post-Ablation Tissue Response Prediction Software
Device class
Class 2
Regulation
21 CFR 892.2052
Advisory panel
Radiology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QZL under 21 CFR 892.2052, via openFDA

Market context for product code QZL

FDA has cleared 2 devices under product code QZL between 2023 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QZL

Recent clearances under product code QZL

Data sourced from openFDA. This site is unofficial and independent of the FDA.