TumorSight Viz

K251766

SimBioSys, Inc. · cleared 2025-07-08 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer.”

Algorithmdeep learning algorithm

source quote (p.8)

“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)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=266 patients · 8 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; tumor segmentation (Dice coefficient)

standards: ISO 14971

Reported performance (2 observations)

diceas written: “Tumor segmentation (n=218) - Volumetric Dice”0.76CI ± 0.26

source quote (p.9)

“0.76±0.26”

diceas written: “Tumor segmentation (n=218) - Surface Dice”0.92CI ± 0.21

source quote (p.9)

“0.92 ± 0.21”

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

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).