FDA-cleared profile
Change Healthcare Canada Company · CT/CTA; MRI · FDA-cleared (510(k))
Authorized purpose: Analyzes CT or MR pixel data to create anatomical descriptors for export and to help identify images, series, and studies.
Overview status: Source-reviewed overview
Workflow role has not yet been reviewed for this navigation pilot.
A tag identifies a documented role; it does not establish compatibility or local acceptance. Methods and sources
Clinical takeaway. Clinical role: Analyzes CT or MR pixel data to create anatomical descriptors for export and to help identify images, series, and studies.
Evidence takeaway. Evidence from the reviewed source record: FDA-reported retrospective validation used separate training, validation, and test sets by modality, no repeat or temporal studies in validation/test, 27 institutions, and age-18-plus subjects.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
Conservative normalization of explicit wording in an exact-submission source.
FDA packet input scope.
FDA packet output scope.
FDA packet user and export context.
Exact FDA limitation boundary.
Submission evidence only; no security or clinical decision-support claim.
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.
Submission evidence only; no security or clinical decision-support claim.
This field has not been curated yet.
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K210719
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Price not public here; enter your quote
Not verified: Pricing information is recorded but not verified against a resolving source.
Match the AI release, system build, configuration and region. Source documentation does not establish acceptance of an installed system.
No specific system/version pairing has completed review for this FDA record. A broad DICOM or product-family statement does not establish a named viewer build's support.
Agree the evidence and acceptance owner with your team and suppliers. Checkmarks apply to this page only and are not acceptance receipts.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR AI Central provides an exact-submission model card for Change Healthcare Anatomical AI; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Controlled catalog enum for FDA CT and MR; CTA is not implied.
Exact FDA supported body-region list.
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, acr ai central product, fda device recall, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall
Recorded state, verification date, notes and sources for fields without a publishable value. Conflicting records stay explicitly unsettled here; no plain settled value is shown for them.
Confirm the intended care setting, patient population, and service line.
No public price or quote for the exact K210719 configuration was established in this review.
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
7 sources - 3 history items
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: intendedUsers, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: postmarketSafety
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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