FDA-cleared profile
Caranx Medical
Authorized purpose: TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.
Product overview
Authorized purpose: TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.
Overview status: Source-reviewed overview
Clinical role: TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.
Evidence from the reviewed source record: K243884 reports multicenter, multivendor C-arm interoperability and patient-data performance validation for landmark and valve tracking.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact intended-user section names skilled and qualified TAVI/TAVR clinical specialists and requires training and certification; it does not establish technologists or generic procedural staff as intended users.
The exact workflow identifies valve inputs and live fluoroscopic data from a cleared X-ray system; it does not establish CT or ultrasound images as subject-device inputs.
The exact workflow describes the raw fluoroscopic display and overlaid landmarks and valve guidance; it does not establish generic measurements or navigation guidance beyond these overlays.
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.
The exact packet identifies fluoroscopy and FDA-cleared C-arm X-ray systems; it does not establish a general angiography modality label. Controlled directory display reconciled from exact FDA wording: Image-intensified fluoroscopic X-ray imaging from an interventional C-arm system. -> Fluoroscopy/Angiography.
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.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K243884 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Validate compatible imaging hardware, acquisition geometry, displays, workstation, exported objects, latency, calibration, and fallback workflow.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. It does not replace the surgeon or interventional cardiologist and excludes prior TAVR or SAVR, non-femoral access, non-tricuspid native valves, specified implants, and patients under 21; use only compatible valves, delivery systems, pigtails, C-arms, and workstation configuration.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: It does not replace the surgeon or interventional cardiologist and excludes prior TAVR or SAVR, non-femoral access, non-tricuspid native valves, specified implants, and patients under 21; use only compatible valves, delivery systems, pigtails, C-arms, and workstation configuration.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
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.
Sensitivity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K243884
Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 0 PubMed and 5 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 0 PubMed and 5 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, fda decision material, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, anatomy, limitations, evidenceSummary, modality, intendedUsers, input, output, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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