QOCA® image Smart RT Contouring System

K231855

Quanta Computer Inc. · cleared 2024-02-13 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.”
Algorithmdeep-learning-based algorithms
source quote (p.3)
“QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.11)
“The subject device has undergone software validation activities in accordance with ... Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”

Validation studies (1)

Retrospective clinical

n=220 cases

endpoints: DICE similarity coefficient (DSC); HD95

standards: IEC 62304: 2006/A1:2016 - Medical device software - Software life cycle processes, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket submissions for Devices Software Functions, Content of Premarket Submission for Management of Cybersecurity in Medical Devices

Reported performance (1 observation)

diceas written: “Median DSC”stated without value
source quote (p.14)
“The subject device achieved a median DSC > 0.80.”

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 2026-07-08.

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/K231855