De Novo · Granted
GrantedBioTraceIO Lite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techsomed Medical Technologies, Ltd. · QZL Post-Ablation Tissue Response Prediction Software
Granted on Dec 22, 2023 as a new device type through De Novo after a 267-day review. 1 later device descends from it.
- Decided
- Dec 22, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- QZL
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN230020 BioTraceIO LiteTechsomed Medical Technologies, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK243084 BioTraceIO Precision (2.0)Techsomed Medical Technologies, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K243084BioTraceIO Precision (2.0)Techsomed Medical Technologies, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230020 | BioTraceIO Lite | Techsomed Medical Technologies, Ltd. | 2023 | — |
| +1 | K243084 | BioTraceIO Precision (2.0) | Techsomed Medical Technologies, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QZL device
- #1 K243084 BioTraceIO Precision (2.0)score 8.6 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243084 | BioTraceIO Precision (2.0) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K243084 (Techsomed Medical Technologies, Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QZL devicesQZL Post-Ablation Tissue Response Prediction Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 | — |
What is it indicated for?
BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment. BioTraceIO Lite generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24 hours post treatment. The information is provided…
Read the full statement (185 words)
BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
BioTraceIO Lite generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24 hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available.
During the ablation procedure BioTraceIO Lite overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image.
BioTraceIO Lite is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.
BioTraceIO Lite is not intended for standalone prediction or for diagnostic purposes.
BioTraceIO Lite does not support the use of multiple needles, either simultaneously or consecutively.
The physician should not rely on BioTraceIO Lite BTM alone in decisions about patient management post treatment nor should BioTraceIO Lite serve as a substitute for any other assessment method, e.g., CT scans.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230020 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230020: BioTraceIO Lite.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230020
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026