BioTraceIO Vision (V1.7)

K251931

Techsomed 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.”
AlgorithmAI algorithms for liver segmentation, liver vessel segmentation and kidney segmentation
source quote (p.11)
“The liver segmentation, liver vessel segmentation and kidney segmentation algorithms for CT and MR (MR for liver only) processing are AI algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: Segmentation Testing; Image Registration Testing; Measurement and Quantification Testing

Reported performance (17 observations)

diceas written: “Mean DICE (CT Liver Segmentation)”0.98
source quote (p.13)
“CT Liver Segmentation Mean DICE 0.98”
diceas written: “Mean DICE (MR Liver Segmentation)”0.93
source quote (p.13)
“MR Liver Segmentation Mean DICE 0.93”
diceas written: “Mean DICE (CT Kidney Segmentation)”0.91
source quote (p.13)
“CT Kidney Segmentation**** Mean DICE 0.91”
diceas written: “Mean DICE (CT Liver Ablation Target Segmentation)”0.82
source quote (p.13)
“CT Liver Ablation Target Segmentation Mean DICE 0.82”
diceas written: “Mean DICE (CT Kidney Ablation Target Segmentation - 1 stroke)”0.79
source quote (p.13)
“1 stroke*** Mean DICE 0.79”
diceas written: “Mean DICE (CT Kidney Ablation Target Segmentation - 2 strokes)”0.79
source quote (p.13)
“2 strokes*** Mean DICE 0.79”
diceas written: “Mean DICE (CT Kidney Ablation Target Segmentation - 3 strokes)”0.79
source quote (p.13)
“3 strokes*** Mean DICE 0.79”
diceas written: “Mean DICE (MR Liver Ablation Target Segmentation)”0.76
source quote (p.13)
“MR Liver Ablation Target Segmentation Mean DICE 0.76”
diceas written: “Mean DICE (CT Liver Ablation Zone Segmentation)”0.88
source quote (p.13)
“CT Liver Ablation Zone Segmentation Mean DICE 0.88”
diceas written: “Mean DICE (CT Kidney Ablation Zone Segmentation - 1 stroke)”0.76
source quote (p.13)
“1 stroke*** Mean DICE 0.76”
diceas written: “Mean DICE (CT Kidney Ablation Zone Segmentation - 2 strokes)”0.77
source quote (p.13)
“2 strokes*** Mean DICE 0.77”
diceas written: “Mean DICE (CT Kidney Ablation Zone Segmentation - 3 strokes)”0.78
source quote (p.13)
“3 strokes*** Mean DICE 0.78”
diceas written: “Mean DICE (CT Kidney Ice Ball Segmentation - 1 stroke)”0.8
source quote (p.13)
“1 stroke*** Mean DICE 0.80”
diceas written: “Mean DICE (CT Kidney Ice Ball Segmentation - 2 strokes)”0.81
source quote (p.13)
“2 strokes*** Mean DICE 0.81”
diceas written: “Mean DICE (CT Kidney Ice Ball Segmentation - 3 strokes)”0.83
source quote (p.13)
“3 strokes*** Mean DICE 0.83”
diceas written: “Mean DICE (CT Liver Vessels Segmentation)”0.72
source quote (p.13)
“Mean DICE 0.72”
diceas written: “Mean Centerline DICE (CT Liver Vessels Segmentation)”0.76
source quote (p.13)
“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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251931