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. The software application does not deliver or depend on energy delivered to or from patients”

AlgorithmVisAble.IO uses several algorithms to perform operations to present information to the user in order for them to evaluate the planned and post ablation zones. These include: Segmentation, Image Registration, Measurement and Quantification. The liver segmentation and liver vessel segmentation algorithms are AI algorithms.

source quote (p.5)

“VisAble.IO uses several algorithms to perform operations to present information to the user in order for them to evaluate the planned and post ablation zones. These include: Segmentation, Image Registration, Measurement and Quantification. 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)

Retrospective clinical

n=50 cases

endpoints: Mean DICE

standards: 21 CFR Part 820.30, FDA "Guidance on Software Contained in Medical Devices", DICOM standard

Retrospective clinical

n=59 cases

endpoints: Mean DICE

standards: 21 CFR Part 820.30, FDA "Guidance on Software Contained in Medical Devices", DICOM standard

Retrospective clinical

n=59 cases

endpoints: Mean DICE

standards: 21 CFR Part 820.30, FDA "Guidance on Software Contained in Medical Devices", DICOM standard

Retrospective clinical

n=100 cases

endpoints: Mean DICE

standards: 21 CFR Part 820.30, FDA "Guidance on Software Contained in Medical Devices", DICOM standard

Retrospective clinical

n=46 cases

endpoints: MCD

standards: 21 CFR Part 820.30, FDA "Guidance on Software Contained in Medical Devices", DICOM standard

Reported performance (4 observations)

diceas written: “Mean DICE (Liver Segmentation)”0.98

source quote (p.10)

“Liver Segmentation ... Primary Endpoint Mean DICE =0.98”

diceas written: “Mean DICE (Ablation Target Segmentation)”0.8

source quote (p.10)

“Ablation Target Segmentation ... Primary Endpoint Mean DICE = 0.80”

diceas written: “Mean DICE (Ablation Zone Segmentation)”0.86

source quote (p.10)

“Ablation Zone Segmentation ... Primary Endpoint Mean DICE = 0.86”

diceas written: “Mean DICE (Liver Vessels Segmentation)”0.72

source quote (p.10)

“Liver Vessels Segmentation ... Primary Endpoint 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). 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).