Authorized purpose: Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
Which images or clinical context are in scope?Modality: Radiological images; modality varies or is not specified in FDA list Anatomy or clinical context: Multi-region Input: Supported CT or MR DICOM studies, contours, treatment-planning metadata, and release-specific workflow inputs.
Who uses it?Intended users: Qualified radiation oncologists, dosimetrists, physicists, therapists, and trained imaging professionals.
What does the software produce?Output: Contours, registrations, measurements, processed images, or planning-workflow objects for qualified review and approval.
What is its most important limitation?Key limitation: Anatomy, modality, structure set, registration, treatment site, software version, and required independent checks are release-specific. Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
Clinical takeaway
Clinical role: Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
Evidence takeaway
Evidence from the reviewed source record: The exact FDA submission K253270 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
Anatomy, modality, structure set, registration, treatment site, software version, and required independent checks are release-specific. Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
Exact submission evidence and the current vendor family material do not establish the exact site's DICOM, worklist, PACS/RIS, identity, routing, display, or fallback behavior.
Deployment and data flow
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
Exact deployment topology, hosting, network boundaries, update mechanism, and local operational requirements are not established for this submission.
Security and privacy
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Current vendor material is product-family context for K253270 only; exact release, enabled options, deployment, and local interoperability require confirmation.
product family · checked 2026-09-04
Vendor material is not exact-release evidence unless that linkage is separately proven.
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.
Evidence summary
The exact FDA submission K253270 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
No exact submission and version-linked sensitivity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.
Reported specificity
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No exact submission and version-linked specificity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA submission-specific verification and validation evidence for K253270
DesignRegulatory verification, validation, and labeling evidence reviewed for exact FDA submission K253270.
PopulationThe labeled population and test materials for exact submission K253270; a general clinical study population is not established here.
Scopeexact submission
Tested versionContour ProtégéAI+ (K253270)
IndependenceSponsor or vendor study
K253270
FDA regulatory evidence is submission-specific but is not independent clinical performance evidence.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
Reimbursement and coding
Not applicable
Not applicable
Not applicable
Checked 2026-09-04
CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify DICOM, HL7/FHIR, PACS/RIS/EHR integration: Exact submission evidence and the current vendor family material do not establish the exact site's DICOM, worklist, PACS/RIS, identity, routing, display, or fallback behavior.
Verify deployment and data flow: Exact deployment topology, hosting, network boundaries, update mechanism, and local operational requirements are not established for this submission.
Verify security and privacy controls: Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
Verify reimbursement and coding relevance: CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-19Last searched
28Fields reviewed
13Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
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, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history8 sources - 3 history items
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