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Post-Ablation Tissue Response Prediction Software

FDA product code QZL · 1 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2052
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-12-27 – 2024-12-27

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.

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