BioTraceIO Vision (V1.7)
K251931Techsomed Medical Technologies · cleared 2025-09-08 · product code QTZ · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“BioTraceIO Vision is a stand-alone software application with tools and features designed to assist users in planning ablation procedures as well as tools for treatment confirmation. The use environment for BioTraceIO Vision is the Operating Room and the hospital healthcare environment such as interventional radiology control room.”
AlgorithmAI algorithms for segmentation, image registration, measurement and quantification
source quote (p.11)
“The liver segmentation, liver vessel segmentation and kidney segmentation algorithms for CT and MR (MR for liver only) processing are Al algorithms.”
Adaptive (vs locked)No
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Bench
sample size not stated
endpoints: Mean DICE; Mean Centerline DICE; MCD
standards: 21 CFR Part 820.30, FDA "Guidance on Software Contained in Medical Devices", DICOM standard
Reported performance (17 observations)
diceas written: “Mean DICE (Liver Segmentation CT)”0.98
source quote (p.13)
“Liver Segmentation Mean DICE 0.98”
diceas written: “Mean DICE (Liver Segmentation MR)”0.93
source quote (p.13)
“Liver Segmentation Mean DICE 0.93”
diceas written: “Mean DICE (Kidney Segmentation CT)”0.91
source quote (p.13)
“Kidney Segmentation**** Mean DICE 0.91”
diceas written: “Mean DICE (Liver Ablation Target Segmentation CT)”0.82
source quote (p.13)
“Liver Ablation Target Segmentation Mean DICE 0.82”
diceas written: “Mean DICE (Kidney Ablation Target Segmentation CT, 1 stroke)”0.79
source quote (p.13)
“1 stroke*** Mean DICE 0.79”
diceas written: “Mean DICE (Kidney Ablation Target Segmentation CT, 2 strokes)”0.79
source quote (p.13)
“2 strokes*** Mean DICE 0.79”
diceas written: “Mean DICE (Kidney Ablation Target Segmentation CT, 3 strokes)”0.79
source quote (p.13)
“3 strokes*** Mean DICE 0.79”
diceas written: “Mean DICE (Liver Ablation Target Segmentation MR)”0.76
source quote (p.13)
“Liver Ablation Target Segmentation Mean DICE 0.76”
diceas written: “Mean DICE (Liver Ablation Zone Segmentation CT)”0.88
source quote (p.13)
“Liver Ablation Zone Segmentation Mean DICE 0.88”
diceas written: “Mean DICE (Kidney Ablation Zone Segmentation CT, 1 stroke)”0.76
source quote (p.13)
“1 stroke*** Mean DICE 0.76”
diceas written: “Mean DICE (Kidney Ablation Zone Segmentation CT, 2 strokes)”0.77
source quote (p.13)
“2 strokes*** Mean DICE 0.77”
diceas written: “Mean DICE (Kidney Ablation Zone Segmentation CT, 3 strokes)”0.78
source quote (p.13)
“3 strokes*** Mean DICE 0.78”
diceas written: “Mean DICE (Kidney Ice Ball Segmentation CT, 1 stroke)”0.8
source quote (p.13)
“1 stroke*** Mean DICE 0.80”
diceas written: “Mean DICE (Kidney Ice Ball Segmentation CT, 2 strokes)”0.81
source quote (p.13)
“2 strokes*** Mean DICE 0.81”
diceas written: “Mean DICE (Kidney Ice Ball Segmentation CT, 3 strokes)”0.83
source quote (p.13)
“3 strokes*** Mean DICE 0.83”
diceas written: “Mean DICE (Liver Vessels Segmentation CT)”0.72
source quote (p.13)
“Liver Vessels Segmentation* (HV+PV) Mean DICE 0.72”
diceas written: “Mean Centerline DICE (Liver Vessels Segmentation CT)”0.76
source quote (p.13)
“Liver Vessels Segmentation* (HV+PV) Mean Centerline DICE 0.76”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).