TumorSight Viz

K231130

SimBioSys, Inc. · cleared 2023-12-26 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).”

Algorithmdeep learning algorithm

source quote (p.7)

“The measurements generated from the device result directly from the segmentation methodology and are an inferred reflection of the performance of the deep learning algorithm.”

Adaptive (vs locked)No

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=163 cases · 6 site(s)

endpoints: Tumor Volume; Tumor-to-breast volume ratio; Tumor longest dimension; Tumor-to-nipple distance; Tumor-to-skin distance; Tumor-to-chest distance; Tumor center of mass; Volume Dice; Surface Dice

standards: ISO 14971

Reported performance (2 observations)

diceas written: “Volume Dice”0.676CI ± 0.289

source quote (p.8)

“0.676 ± 0.289”

diceas written: “Surface Dice”0.873CI ± 0.264

source quote (p.8)

“0.873 ± 0.264”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K251766 (decision 2025-07-08) from SimBioSys, Inc. for a matching device line ("TumorSight Viz") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251766
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243189 (decision 2024-10-25) from SimBioSys, Inc. for a matching device line ("TumorSight Viz") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243189

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).