FDA-cleared profile
TeraRecon, Inc · CT/CTA; MRI · FDA-cleared (510(k))
Authorized purpose: Analyzes functional, dynamic, and derived CT or MRI datasets for brain perfusion, vascular assessment, tissue blood volume, and related parametric maps to assist physician diagnosis.
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 functional, dynamic, and derived CT or MRI datasets for brain perfusion, vascular assessment, tissue blood volume, and related parametric maps to assist physician diagnosis.
Evidence takeaway. Evidence from the reviewed source record: FDA reports software testing, quantitative phantom testing, qualitative clinical user evaluation, and quantitative Tmax comparison; sample size and sensitivity/specificity are not reported.
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 input scope.
FDA output description.
FDA intended-user statement.
FDA-labeled use boundary; no broader performance or deployment claim is made.
Submission-reported FDA evidence summary, not independent validation.
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-reported FDA evidence summary, not independent validation.
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.
K220349
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 mode explicitly reported in the exact-submission ACR model card; hosting region 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.
Vendor statement; the certificate was not read (a certificate PDF is hosted on the same owning domain). Applicant name variants (TeraRecon Inc. with punctuation/case variants) are bridged via the identical distinctive name. Exact-release scope is not established.
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.
Cloud-based deployment is explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.
exact submission · checked 2026-09-01Scanner 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 TeraRecon Neuro; 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.
FDA states CT or MRI; normalized to the controlled catalog enum.
FDA packet scopes the body part to the head and entire brain.
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 K220349 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.
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.
8 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, deployment, anatomy, evidenceStudies, implementationCapabilities
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: postmarketSafety
Scope: security
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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