OncoStudio (OS-01)

K242994

OncoSoft. Co., Ltd. · cleared 2025-02-24 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.7)

“OncoStudio is a standalone software that provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images.”

Algorithmdeep-learning-based automatic contouring

source quote (p.7)

“OncoStudio is a standalone software that provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.16)

“"Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", on September 27, 2023”

Validation studies (1)

Standalone

n=310 images · 3 site(s)

endpoints: mean Dice coefficient (DSC) of structures for each anatomical region (Head & Neck, Thorax, Abdomen, and Pelvis)

standards: RTOG

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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).