QZL — Post-Ablation Tissue Response Prediction Software Class II
FDA product code QZL covers "Post-Ablation Tissue Response Prediction Software", a Class II medical device regulated under 21 CFR 892.2052. Submissions are reviewed by the Radiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.