VisAble.IO

K240773

Techsomed · cleared 2024-04-15 · product code QTZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“VisAble.IO 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 VisAble.IO is the Operating Room and the hospital healthcare environment such as interventional radiology control room.”
AlgorithmAI algorithms
source quote (p.9)
“The liver segmentation and liver vessel segmentation algorithms for CT processing are Al algorithms. The training and model validation dataset characteristics are as follows:”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (12)

Bench

sample size not stated

Retrospective clinical

n=1,091 images · 38 site(s)

endpoints: Mean DICE

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=393 images · 36 site(s)

endpoints: Mean DICE

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=418 images · 3 site(s)

endpoints: Mean DICE

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=59 patients

endpoints: Mean DICE

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=59 patients

endpoints: Mean DICE

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=100 patients

endpoints: Mean DICE

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=25 patients

endpoints: Mean DICE

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=50 patients

endpoints: Mean DICE

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=46 patients

endpoints: MCD*

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=25 patients

endpoints: MCD*

standards: 21 CFR Part 820.30, DICOM standard

Retrospective clinical

n=18 patients

endpoints: MCD*

standards: 21 CFR Part 820.30, DICOM standard

Reported performance (6 observations)

diceas written: “Mean DICE (Liver Segmentation CT)”0.98
source quote (p.10)
“Mean DICE =0.98”
diceas written: “Mean DICE (Ablation Target Segmentation CT)”0.82
source quote (p.10)
“Mean DICE = 0.82”
diceas written: “Mean DICE (Ablation Zone Segmentation CT)”0.88
source quote (p.10)
“Mean DICE = 0.88”
diceas written: “Mean DICE (Liver Vessels Segmentation CT)”0.72
source quote (p.10)
“Mean DICE = 0.72”
diceas written: “Mean DICE (Liver Segmentation MR)”0.93
source quote (p.10)
“Mean DICE = 0.93”
diceas written: “Mean DICE (Ablation Target Segmentation MR)”0.76
source quote (p.10)
“Mean 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/K240773