510(k) · Cleared
ClearedBioTraceIO Vision (V1.7)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techsomed Medical Technologies · QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
Cleared on Sep 8, 2025 as substantially equivalent to K240773 (Techsomed, 2024) after a 76-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Sep 8, 2025
- Review
- 76 days
- Class
- Class II
- Product code
- QTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001284 (2000). 9 ancestors in all, the oldest K974513 (1998). No later device cites it as a predicate yet.
- Root · 7 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 6 generations backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- 5 generations backK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- 4 generations backK150313 Ablation ConfirmationNeuwave Medical, Inc. · 2015
- 3 generations backK202297 Aline Ablation IntelligenceMirada Medical, Ltd. · 2020
- 2 generations backK223639 VisAble.IOTechsomed · 2023
- 1 generation backK240773 VisAble.IOTechsomed · 2024
- This deviceK251931 BioTraceIO Vision (V1.7)Techsomed Medical Technologies · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −6 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| −5 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| −4 | K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015 | — |
| −3 | K202297 | Aline Ablation Intelligence | Mirada Medical, Ltd. | 2020 | — |
| −2 | K223639 | VisAble.IO | Techsomed | 2023 | — |
| −1 | K240773 | VisAble.IO | Techsomed | 2024 | — |
| 0 (this device) | K251931 | BioTraceIO Vision (V1.7) | Techsomed Medical Technologies | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
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 QTZ? 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 QTZ device
- #1 K252947 HistoSonics® Planning Toolscore 14.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K240773 | VisAble.IOSummary page 5…Management and Processing System (21 CFR 892.2050) Regulatory Class: Class II Product Code: QTZ, QIH, LLZ Predicate Devices 510(K) Number K240773 Trade Name BioTraceIO Vision 1.4 Manufacturer Techsomed Medical Technol… | 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?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All QTZ devicesQTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QTZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QTZ
351in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QTZ
No recall names QTZ since 2007.
Adverse event reports per year · QTZ
No MAUDE report names QTZ 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 | 1 | — | 0 | 0 |
| 2023 | 3 | 351 | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures. BioTraceIO Vision is controlled by the user via a user interface. BioTraceIO Vision imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures. BioTraceIO Vision is used to assist physicians in planning ablation procedures, including…
Read the full statement (103 words)
BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.
BioTraceIO Vision is controlled by the user via a user interface.
BioTraceIO Vision imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.
BioTraceIO Vision is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. BioTraceIO Vision is used to assist physicians in confirming ablation zones.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251931: BioTraceIO Vision (V1.7).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251931
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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