OncoStudio (OS-01)

K242994

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

FDA 510(k) summary for OncoStudio (OS-01) (K242994)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
1
Product code
QKB
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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
PCCPNo
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)

Retrospective clinical

n=310 images · 3 site(s)

endpoints: mean Dice coefficient (DSC)

Reported performance (1 observation)

diceas written: “mean Dice coefficient (DSC)”stated without value
source quote (p.16)
“For the structures being compared, the mean Dice coefficient (DSC) of structures for each anatomical region (Head & Neck, Thorax, Abdomen, and Pelvis) should meet the established criteria.”

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
0
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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code QKB

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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TAIMedImg DeepMets

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AI-Rad Companion Organs RT

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242994