Radiology AI Directory

FDA-cleared profile

RadOncAI

Informai

RadOncAI provides AI-guided dose prediction from CT simulation and clinician-defined treatment-planning structures for adult head-and-neck malignant or benign disease.

Radiotherapy planning
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
RadOncAI provides AI-guided dose prediction from CT simulation and clinician-defined treatment-planning structures for adult head-and-neck malignant or benign disease.
FDA source Exact FDA submission Checked 2026-09-04
Intended users
Radiation oncologists, medical physicists, and dosimetrists.
FDA source Exact FDA submission Checked 2026-09-04
Care setting and population
Radiation-oncology planning and review environments within hospitals or other professional treatment facilities.
FDA source Exact FDA submission Checked 2026-09-04
Workflow role
RadOncAI provides AI-guided dose prediction from CT simulation and clinician-defined treatment-planning structures for adult head-and-neck malignant or benign disease.
FDA source Exact FDA submission Checked 2026-09-04
Required input
CT or MR treatment-planning images, target structures, organs-at-risk information, and other labeled planning inputs.
FDA source Exact FDA submission Checked 2026-09-04
Output and human action
Contours, dose predictions, synthetic CT, registration, or other treatment-planning information described in the exact FDA labeling.
FDA source Exact FDA submission Checked 2026-09-04
Limitations
A radiation oncologist, physicist, or dosimetrist must review, revise, and approve the output; the software is not a diagnosis, autonomous treatment decision, or radiation-delivery system.
FDA source Exact FDA submission Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K253050
FDA source Exact FDA submission Checked 2026-08-31
Modality
Radiotherapy Planning Imaging
FDA source Exact FDA submission Checked 2026-09-04
Anatomy
Head and neck
FDA source Exact FDA submission Checked 2026-09-04
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2026-06-18
FDA source Exact FDA submission Checked 2026-08-31
FDA status
FDA-cleared
FDA source Exact FDA submission Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Accepts CT simulation, target, and organ-at-risk inputs and exports DICOM RT Dose to a compatible treatment-planning or DICOM-RT workflow.
FDA source Exact FDA submission Checked 2026-09-04
Deployment and data flow
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-04

Deployment details for the exact cleared configuration are not established in the public FDA decision material.

Security and privacy
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.

Training and support
Use by the qualified healthcare professionals identified for the exact labeled workflow; site-specific competency and training requirements remain to be established locally.
FDA source Exact FDA submission Checked 2026-09-04
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-04

Post-deployment monitoring, drift thresholds, alerting, and revalidation commitments for the exact configuration require vendor and site confirmation.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K253050 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Accepts CT simulation, target, and organ-at-risk inputs and exports DICOM RT Dose to a compatible treatment-planning or DICOM-RT workflow.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use 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. A radiation oncologist, physicist, or dosimetrist must review, revise, and approve the output; the software is not a diagnosis, autonomous treatment decision, or radiation-delivery system.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

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.

product family · checked 2026-09-04

No exact-product price was found in the evidence set; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes; exact monitoring thresholds and vendor commitments are unknown.

exact submission · checked 2026-09-04

Establish ownership for data quality, overrides, drift, incidents, recalls, and change control.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
The exact FDA decision material reports a 500-case adult head-and-neck radiotherapy validation with PTV and OAR acceptance testing and clinician review. These are manufacturer-submitted regulatory data, not independent clinical validation or a guarantee of local performance.
FDA source Exact FDA submission Checked 2026-09-04
Reported sensitivity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

No exact-product, version-specific sensitivity endpoint was established for this submission in the evidence set.

Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04

No exact-product, version-specific specificity endpoint was established for this submission in the evidence set.

Validation cohort

500 patients

Patients in the manufacturer-submitted adult head-and-neck validation cohort in Adults with head-and-neck disease in the exact FDA validation package.

Tested version: Exact FDA submission release; version not separately stated in the public decision material
Source

PTV equivalence tests meeting margin

9 tests

Tests within the stated +/-300 cGy equivalence margin in The 500-case adult head-and-neck validation cohort.

Tested version: Exact FDA submission release; version not separately stated in the public decision material
Source

OAR non-inferiority metrics meeting margin

21 metrics

Metrics within the stated +300 cGy non-inferiority margin in The 500-case adult head-and-neck validation cohort.

Tested version: Exact FDA submission release; version not separately stated in the public decision material
Source

Clinical acceptability

100 percent

Reviewer assessments judged clinically acceptable in 50 cases reviewed by 3 board-certified radiation oncologists, 150 assessments.

Tested version: Exact FDA submission release; version not separately stated in the public decision material
Source

OAR achievability

98.7 percent

Reviewer assessments judged achievable for organs at risk in 50 cases reviewed by 3 board-certified radiation oncologists, 150 assessments.

Tested version: Exact FDA submission release; version not separately stated in the public decision material
Source

K253050 FDA evidence package for RadOncAI

Manufacturer-submitted retrospective regulatory validation with an independent clinician-review component; not independent clinical validation. · Adults with head-and-neck disease in the exact RadOncAI validation package.

exact submission · Tested version: Exact FDA submission release; version not separately stated in the public decision material · n=500 · 2 sites · Sponsor or vendor study

K253050

Evidence submitted for the exact FDA decision is not independent clinical validation. Local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Economics and lifecycle

Budget and ongoing governance

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 list price for the exact cleared configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS radiation-oncology material. Evaluate net planning or delivery value within the radiotherapy service line.
Public source Not applicable Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Reviewed CMS material is not a product-specific price or coverage determination; do not infer reimbursement from FDA clearance.

Source

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
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K253050 by native exact submission identifier. This does not exclude product-family, later, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
9Source classes checked
0Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads

This submission was added after the prior exact-submission extraction and remains queued for source review. Exact FDA decision material was reviewed for identity and labeled use. Optional literature, trial, and recall candidates were not promoted without exact product or version applicability; commercial, security, and performance claims remain unknown where not established. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-04.

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