FDA product code · Radiology
Post-Ablation Tissue Response Prediction Software
2 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 88 days (half between 88 and 88). No recall names this code. The most-cited predicate is DEN230020, named by 1 later device.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QZL at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · QZL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QZL
Too few QZL 510(k)s in any year since 2007 to give a median.
Recalls per year · QZL
No recall names QZL since 2007.
Adverse event reports per year · QZL
No MAUDE report names QZL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QZL? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report