VisAble.IO

K223639

TechsoMed · cleared 2023-08-28 · 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.”
AlgorithmAI algorithms
source quote (p.9)
“The liver segmentation and liver vessel segmentation algorithms are AI algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (5)

Standalone

n=1,091 images · 38 site(s)

endpoints: Mean DICE

Standalone

n=393 images · 36 site(s)

endpoints: Mean DICE

Standalone

n=59 cases

endpoints: Mean DICE

Standalone

n=59 cases

endpoints: Mean DICE

Standalone

n=46 cases

endpoints: Mean Corresponding Distance

Reported performance (4 observations)

diceas written: “Mean DICE (Liver Segmentation)”0.98
source quote (p.10)
“Mean DICE =0.98”
diceas written: “Mean DICE (Ablation Target Segmentation)”0.8
source quote (p.10)
“Mean DICE = 0.80”
diceas written: “Mean DICE (Ablation Zone Segmentation)”0.86
source quote (p.10)
“Mean DICE = 0.86”
diceas written: “Mean DICE (Liver Vessels Segmentation)”0.72
source quote (p.10)
“Mean DICE = 0.72”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K240773 (decision 2024-04-15) from Techsomed for a matching device line ("VisAble.IO") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K240773

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/K223639