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; Volumetric Dice; Surface Dice; Abs. Distance Error (Longest Dimension); Abs. Distance Error (Tumor to Skin); Abs. Distance Error (Tumor to Chest); Abs. Distance Error (Tumor to Nipple); Abs. Volume Error (Tumor Volume)

standards: ISO 14971

Reported performance (2 observations)

diceas written: “Volumetric Dice”0.76CI ±0.26
source quote (p.9)
“Volumetric Dice 0.76±0.26”
diceas written: “Surface Dice”0.92CI ± 0.21
source quote (p.9)
“Surface Dice 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

0
recalls in product code, 24mo
3
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/K251766