Adjunctive measurement of the RV/LV ratio as a clinical metric used by medical professionals to quantify severity of right-heart strain in adults evaluated with CTPA; the annotated measurements support, but do not replace, clinical assessment.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Adjunctive measurement of the RV/LV ratio as a clinical metric used by medical professionals to quantify severity of right-heart strain in adults evaluated with CTPA; the annotated measurements support, but do not replace, clinical assessment.
Adjunctive quantitative aid within the integrated Rapid Platform; results are not intended for stand-alone clinical decision-making and do not preclude clinical assessment of the CTPA case.
Annotated images with the ventricular measurement locations, quantitative maximal right- and left-ventricular diameters, the RV/LV ratio, a visual color-overlay result, a text report and a JSON text file containing quantitative measurement results; DICOM Secondary Capture is also described.
The labeled population is adults with volumetric CTPA. Rapid RV/LV is not intended for stand-alone clinical decision-making and must not preclude clinical assessment. FDA validation used 124 cases with expert ground truth and scanners from GE, Philips, Toshiba and Siemens; performance outside the submitted conditions was not established here.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The module operates within the integrated Rapid Platform, accepts CTPA DICOM, uses a command-line interface and provides reports, DICOM Secondary Capture and JSON quantitative output for downstream review or integration.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
RapidAI's current platform security and compliance one-pager states that its portfolio uses encryption at rest and in transit, role-based access control, monitoring/logging and listed HIPAA, GDPR, ISO 13485, ISO 27001, ISO 27701 and SOC 2 Type 1 claims.
Vendor supplied
Vendor-wide
Checked 2026-09-07
This is a current vendor-wide statement, not an independent attestation for the exact K223396 release; site-specific architecture, retention, contractual scope and current certification evidence remain unestablished.
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Integrated Rapid Platform and DICOM outputs
The cleared module operates within the integrated Rapid Platform, accepts CTPA DICOM through a command-line interface and produces annotated images, reports, DICOM Secondary Capture and JSON quantitative measurement results.
RapidAI's current PE page lists Rapid PE RV/LV as a PE solution and describes bringing AI results, source imaging and clinical data into one platform, with EHR integration, care-team communication and analytics described at the family level.
product family · checked 2026-09-07
The current family page does not establish exact K223396 release, hosting, connector, price or performance terms.
RapidAI's current security one-pager lists encryption at rest and in transit, role-based access control, monitoring/logging, secure development practices and a vendor-stated compliance framework for its platform portfolio.
vendor wide · checked 2026-09-07
This is vendor-supplied portfolio context and is not independent confirmation of exact K223396 controls or contractual scope.
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.
Evidence summary
Final FDA validation included 124 CTPA cases with ground truth established by three experts. The reported average slope was 1.1, average intercept -0.2, Bland-Altman mean bias 0.023 and mean absolute error 3.8 mm; the source text reports the associated confidence intervals, including malformed intercept-CI formatting.
DesignStandalone performance validation comparing automated ventricular measurements with ground truth established by three experts, including regression and Bland-Altman endpoints.
Population124 CTPA cases; the FDA summary reports a 44% male and 56% female split, ages 26-93, with GE, Philips, Toshiba and Siemens scanners.
Scopeexact submission
Tested versionRapid RV/LV configuration submitted in K223396
Samplen=124
IndependenceSponsor or vendor study
K223396
The FDA source prints a malformed confidence-interval expression for the intercept; the reported intercept value is preserved without reconstructing or recalculating that interval.
DesignAlgorithm development dataset described in the FDA 510(k) summary; this is not the final clinical performance validation cohort.
Population516 CTPA cases from multiple sites and Siemens, GE, Toshiba and Philips scanners; the submission describes an 80% validation and 20% training split.
Scopeexact submission
Tested versionRapid RV/LV configuration submitted in K223396
Samplen=516
IndependenceSponsor or vendor study
K223396
The source wording for the development split is retained; this dataset is not used as a substitute for the 124-case final validation.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-07
No public price or quote for the exact K223396 configuration was reviewed.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
Payer policy research was outside this worker's scope.
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
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-07
The exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Buyer worksheet
Open questions to take to the vendor
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: No public price or quote for the exact K223396 configuration was reviewed.
Verify reimbursement and coding relevance: Payer policy research was outside this worker's scope.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: The exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-07Last searched
23Fields reviewed
11Source classes checked
20Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored candidate metadata was screened. The broad Rapid RV/LV query returned 20 PubMed identifiers without exact K223396 linkage established in metadata; no full paper was reviewed and no candidate is promoted as product evidence. The current discovery snapshot contains 20 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, vendor technical documentation, stored candidate metadata, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history8 sources - 2 history items
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