FDA product code QZL: Post-Ablation Tissue Response Prediction Software
QZL is the FDA product code for post-ablation tissue response prediction software. It is a Class II device, regulated under 21 CFR 892.2052 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under QZL, 1 in the last five years. The average 510(k) review took 88 days (median 88); 88 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Post-Ablation Tissue Response Prediction Software |
| Device class | Class II |
| Regulation | 21 CFR 892.2052 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for QZL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 88 |
Compare with all 510(k) review times · Search every QZL clearance
Top QZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Techsomed Medical Technologies , Ltd. | 1 | 2024-12-27 |
Most recent QZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243084 | Techsomed Medical Technologies , Ltd. | BioTraceIO Precision (2.0) | 2024-12-27 | 88 |
Recalls for QZL devices
openFDA lists no recalls for product code QZL.
Frequently asked questions
What is FDA product code QZL?
QZL is the FDA product code for post-ablation tissue response prediction software. It is a Class II device, regulated under 21 CFR 892.2052 and reviewed by the Radiology panel.
What device class is QZL?
Class II, regulation 21 CFR 892.2052. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZL?
Across 1 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most QZL clearances?
Techsomed Medical Technologies , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QZL
- Run a recall and safety report across every QZL manufacturer
- Watch product code QZL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times