FDA-cleared profile
Quanta Computer Inc.
Authorized purpose: QOCA image Smart RT Contouring System automatically contours DICOM CT imaging data using deep-learning algorithms. Generated contours may be used as input to external-beam radiation-therapy planning and are output as RTSTRUCT objects for radiation-oncology departments.
Product overview
Authorized purpose: QOCA image Smart RT Contouring System automatically contours DICOM CT imaging data using deep-learning algorithms. Generated contours may be used as input to external-beam radiation-therapy planning and are output as RTSTRUCT objects for radiation-oncology departments.
Overview status: Source-reviewed overview
Clinical role: QOCA image Smart RT Contouring System automatically contours DICOM CT imaging data using deep-learning algorithms. Generated contours may be used as input to external-beam radiation-therapy planning and are output as RTSTRUCT objects for radiation-oncology departments.
Evidence from the reviewed source record: The exact FDA 510(k) decision material for K231855 identifies QOCA® image Smart RT Contouring System and describes the indicated use summarized in this dossier. It is regulatory evidence for the exact submission, not independent clinical validation. No performance or outcome claim is promoted without exact product and version linkage.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
The exact FDA material describes this input or interface boundary; local interoperability acceptance remains necessary.
The exact FDA material describes this release-level deployment boundary; hosting, contracts, security, availability, and site configuration remain separate evidence.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K231855 before acceptance. Later family features are not evidence for this exact submission.
exact submission · checked 2026-09-04The FDA indication describes DICOM CT input, RTSTRUCT output, and a web-based interface for settings, user settings, progress, and other functions; validate DICOM RT structure transfer, patient identity, review, acceptance, and rollback locally. Test representative identifiers, geometry, measurements, units, routing, failure handling, and round trips locally.
exact submission · checked 2026-09-04The FDA indication describes a web-based management interface but does not establish hosting, security, availability, retention, or site responsibility for the exact release. Security, availability, retention, and service responsibilities remain unverified.
exact submission · checked 2026-09-04Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The FDA indication limits valid input to adult-patient DICOM images, states that the software does not automatically detect or contour lesions, and requires appropriate treatment-planning or interactive-contouring software to review, edit, and accept the contours.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs. No exact-product price was found.
product family · checked 2026-09-04Monitor by exact hardware, software, model, algorithm, reconstruction, or configuration version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The FDA indication limits valid input to adult-patient DICOM images, states that the software does not automatically detect or contour lesions, and requires appropriate treatment-planning or interactive-contouring software to review, edit, and accept the contours.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Sensitivity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Specificity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K231855
The FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared or approved configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: reimbursement, radiationTherapyPaymentContext
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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