CardIQ Suite analyzes 2D or 3D cardiac CT DICOM data for visualization and measurement of cardiovascular anatomy, coronary calcium scoring, coronary review, heart-fat estimation, and treatment or follow-up support under clinician review.
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
CardIQ Suite analyzes 2D or 3D cardiac CT DICOM data for visualization and measurement of cardiovascular anatomy, coronary calcium scoring, coronary review, heart-fat estimation, and treatment or follow-up support under clinician review.
FDA source Exact FDA submission Checked 2026-09-07
Post-processing and visualization for coronary review, calcium scoring, cardiovascular measurements, treatment planning, and follow-up; results remain subject to clinician interpretation.
FDA source Exact FDA submission Checked 2026-09-07
Cardiac CT DICOM data, including non-contrast and angiographic studies; calcium scoring requires ECG-gated non-contrast CT with 120 kVp, 24-35 cm DFOV, and slice thickness no greater than 3 mm.
FDA source Exact FDA submission Checked 2026-09-07
Agatston and calcium-volume scores by vessel and total; coronary segmentation, labeling, centerline, and lumen measurements; heart and heart-fat segmentation/estimates; percentile context; DICOM Structured Report, batch DICOM Secondary Capture, and PDF report outputs.
FDA source Exact FDA submission Checked 2026-09-07
Calcium scoring is protocol-dependent and requires the stated gated non-contrast CT inputs. Heart-fat information is informational; all segmentation, measurements, and follow-up outputs require qualified clinical review. The regulatory results are not independent clinical-outcome evidence.
FDA source Exact FDA submission Checked 2026-09-07
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
K243672
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The exact submission processes cardiac CT DICOM data and provides DICOM SR, batch SC, and PDF report outputs; local PACS/RIS routing, identifiers, and report ingestion require acceptance testing.
FDA source Exact FDA submission Checked 2026-09-07
The exact submission is deployed on the GE AW Server platform; reviewed sources do not establish the current site infrastructure, hosting topology, retention, availability, or service-level boundary for a particular installation.
FDA source Exact FDA submission Checked 2026-09-07
Reviewed sources checked Exact FDA submission Checked 2026-09-07
The reviewed exact packet, GE product page, and DICOM conformance statement do not establish current scoped security controls, certification scope, PHI flow, retention, access control, audit, or incident response.
Training and support
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-07
Reviewed sources establish qualified clinical use but do not establish an exact-version training curriculum, competency assessment, or support terms.
Monitoring and change control
Monitor protocol eligibility, calcium-score inputs, segmentation and measurement edits, report/export completeness, PACS delivery, reader overrides, failed or repeated analyses, downtime, updates, complaints, and recalls by exact K243672 release.
FDA source Exact FDA submission Checked 2026-09-07
Buyer acceptance guidance derived from the exact FDA workflow and validation scope; it is not a claimed vendor monitoring service.
The exact FDA submission runs on the GE AW Server platform and processes cardiac CT DICOM studies; confirm the installed AW Server release, compute sizing, storage, backup, and upgrade path with the site and vendor.
GE describes CardIQ Suite as an integrated cardiac workflow for automated coronary territories, segmentation, scores, CCTA review, multiplanar views, and measurements; current page claims are family-level context for buyer workflow evaluation.
product family · checked 2026-09-07
Current GE family page; confirm which modules, licenses, and workflow features are included in the K243672 configuration.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
K243672 FDA evidence is a regulatory validation with heart-segmentation and heart-fat tests on 111 cardiac CT examinations and a separate lumen-diameter endpoint on 94 examinations containing 353 narrowings; overall totals and subgroup overlap were not reported, and no independent paper or trial was promoted in this timeboxed review.
FDA source Exact FDA submission Checked 2026-09-07
Needs research Exact FDA submission Checked 2026-08-31
This field has not been curated yet.
Reported specificity
Research pending
Needs research Exact FDA submission Checked 2026-08-31
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.
K243672 CardIQ Suite heart and heart-fat regulatory validation
Retrospective regulatory validation of heart segmentation and heart-fat segmentation workflows. · 111 cardiac CT examinations used for the FDA-described heart-segmentation and heart-fat tests.
exact submission · Tested version: CardIQ Suite configuration described in K243672 · n=111 · Sponsor or vendor study
K243672
FDA reports heart-segmentation success greater than 90% and heart-fat average Dice of at least 90% in this test set; these are bounds, not observed numeric point estimates. The separate lumen-diameter endpoint used 94 examinations containing 353 narrowings; overall totals and subgroup overlap were not reported. Manufacturer-submitted regulatory evidence, not an independent clinical-outcome study.
K243672 CardIQ Suite lumen-diameter subgroup validation
Retrospective regulatory validation of lumen-diameter measurements against reference measurements. · 94 cardiac CT examinations containing 353 narrowings for the FDA-described lumen-diameter endpoint.
exact submission · Tested version: CardIQ Suite configuration described in K243672 · n=94 · Sponsor or vendor study
K243672
This endpoint uses a subgroup distinct from the 111-examination heart and heart-fat validation context. No exact total unique-case count across the subgroups is inferred. Manufacturer-submitted regulatory evidence.
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 2026-09-07
No public list price or contract unit for the exact K243672 configuration was established in the reviewed official sources.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-07
CMS plaque-policy review was not applied to this dossier; no product-specific coverage determination is made.
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 wave22 exact-submission recall query returned no native recall record for K243672. This does not establish absence of family, later-version, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-07
Verify security and privacy controls: The reviewed exact packet, GE product page, and DICOM conformance statement do not establish current scoped security controls, certification scope, PHI flow, retention, access control, audit, or incident response.
Verify training: Reviewed sources establish qualified clinical use but do not establish an exact-version training curriculum, competency assessment, or support terms.
Verify pricing and total cost: No public list price or contract unit for the exact K243672 configuration was established in the reviewed official sources.
Verify reimbursement and coding relevance: CMS plaque-policy review was not applied to this dossier; no product-specific coverage determination is made.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
11Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
The stored PubMed and ClinicalTrials.gov candidate arrays were screened and were empty. No paper or trial was promoted; empty stored arrays do not establish that no external literature or trials exist. 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, vendor product page, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall
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