OncoStudio (OS-01)

OncoSoft. Co., Ltd. · RT auto-contouring

What it does

Automatically outlines structures on ct images, saving time that would otherwise go into manual contouring.

Who it's for

Radiation-oncology, physics, and radiology teams that contour structures as part of planning or reporting.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)

Submission #K242994

Product codeQKB

Decision dateFeb 24, 2025

PanelRadiology

FDA recordaccessdata

EU (CE)

Statusunknown

Risk class—

Notified body—

EMDN code—

Basic UDI-DI—

AI Act class—

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

CompanyOncoSoft. Co., Ltd.

Foundedunknown

Cite this page

RadPigeon. "OncoStudio (OS-01) (OncoSoft. Co., Ltd.)." AI Devices registry. https://radpigeon.news/ai/device/oncostudio-os-01

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.