FDA-cleared profile
HeartVista, Inc.
Accessory acquisition, reconstruction, and display of cardiovascular MR images on compatible 1.5T and 3T whole-body MRI systems for trained-physician interpretation.
Product overview
Accessory acquisition, reconstruction, and display of cardiovascular MR images on compatible 1.5T and 3T whole-body MRI systems for trained-physician interpretation.
Overview status: Field-derived fact summary This section is assembled from the sourced field records below; it is not a source-reviewed editorial overview.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
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.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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.
Vista AI describes RTHawk as a real-time MRI acquisition and reconstruction engine; the reviewed page is explicitly research-use context and does not establish current clinical configuration terms.
product family · checked 2026-09-08Confirm exact-release availability, interfaces, hosting, security, support, and commercial terms during procurement.
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.
No exact-version evidence summary has been curated yet.
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.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public price or quote for the exact K183274 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.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA support assessed on 2026-09-19. Packet-supported facts: purpose, modality, anatomy, input, output, limitations; packet-unavailable facts: intendedUsers, evidenceSummary. Candidate literature and postmarket candidates remain in their existing review state. 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 summary, vendor research page, fda device recall, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, input, output, limitations
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: postmarketSafety
Scope: productFamily, implementationCapabilities
Regulatory record
510(k)
Research record
fda record reviewed
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GE Medical Systems,LLC (GE Healthcare)
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ARTERYS INC.
Web-accessible post-processing for viewing and quantifying cardiovascular MR images in DICOM format.