510(k) · Cleared
ClearedBioTraceIO Precision (2.0)
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
Cleared on Dec 27, 2024 as substantially equivalent to DEN230020 (Techsomed Medical Technologies, Ltd., 2023) after an 88-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Dec 27, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- QZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230020 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230020 BioTraceIO LiteTechsomed Medical Technologies, Ltd. · 2023
- This deviceK243084 BioTraceIO Precision (2.0)Techsomed Medical Technologies, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230020 | BioTraceIO Lite | Techsomed Medical Technologies, Ltd. | 2023 | — |
| 0 (this device) | K243084 | BioTraceIO Precision (2.0) | Techsomed Medical Technologies, Ltd. | 2024 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN230020 | BioTraceIO LiteSummary page 5…ost-Ablation Tissue Response Prediction Software (CFR 892.2052) Regulatory Class: Class II Product Code: QZL Predicate Device 510(k) Number DEN230020 Trade Name BioTraceIO Precision Manufacturer TechsoMed Medical Technologies… | 2023 |
| † | K240773 | VisAble.IO | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2024, 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 Precision 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 Precision 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 24hours post treatment. The information is…
Read the full statement (208 words)
BioTraceIO Precision 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 Precision 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 24hours 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 Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image.
BioTraceIO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.
BioTraceIO Precision is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Precision does not support the use of multiple needles, either simultaneously or consecutively.
Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success.
The physician should not rely on BioTraceIO Precision BTM alone in decisions about patient management post treatment nor should BioTraceIO Precision 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/K243084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243084: BioTraceIO Precision (2.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243084
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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