FDA-cleared profile
DIACARDIO, LTD.
Non-invasive processing of previously acquired echocardiographic images to detect and measure the left-ventricular wall and calculate left-ventricular function.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Identify the intended clinical user and the human action expected after the output.
Confirm the intended care setting, patient population, and service line.
Conservative normalization of explicit wording in an exact-submission source.
Conservative normalization of explicit wording in an exact-submission source.
Conservative normalization of explicit wording in an exact-submission source.
Confirm contraindications, unsupported populations, scanners, protocols, and known failure modes.
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.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
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.
GE HealthCare's LVivo EF support material describes automated left-ventricular border tracing and EF, EDV, and ESV calculation from an apical four-chamber ultrasound view.
product family ยท 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 K161382 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 scope controls clinical claims. ACR and official vendor material provide bounded catalog or product-family context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. 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 product page, fda device recall, literature index, trial registry, 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
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: product_family, clinical_workflow, outputs, limitations
Scope: postmarketSafety
Regulatory record
510(k)
Research record
fda record reviewed
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