Product code QZL

Device name

Post-Ablation Tissue Response Prediction Software

Medical specialty

Radiology

Device class

2

Regulation number

892.2052

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset