QZL
- Product code
- QZL
- Device name
- Post-Ablation Tissue Response Prediction Software
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2052
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243084 | 2024-12-27 | Techsomed Medical Technologies , Ltd. | BioTraceIO Precision (2.0) | |
| DEN230020 | 2023-12-22 | Techsomed Medical Technologies , Ltd. | BioTraceIO Lite | — |
Official FDA classification page: QZL
Classification and pathway per current FDA publications. Data from openFDA (CC0).