FDA-cleared profile
Therenva SAS
EndoNaut overlays preoperative three-dimensional vascular anatomy on live fluoroscopy and supports semi-automatic registration and motion detection for selected aneurysm, angioplasty, stenting, and embolization procedures.
Product overview
EndoNaut overlays preoperative three-dimensional vascular anatomy on live fluoroscopy and supports semi-automatic registration and motion detection for selected aneurysm, angioplasty, stenting, and embolization procedures.
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.
Previous value withdrawn: The exact FDA decision-summary packet reviewed on 2026-09-19 does not establish this claim.
The replacement uses the packet's direct description of the imaging inputs and removes unsupported ultrasound and generic user-input wording.
The replacement uses the packet's direct fusion and registration description.
The replacement uses the packet's explicit anatomic procedure boundary.
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.
Current vendor materials are product-family evidence for K212383; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Current vendor materials are product-family evidence for K212383; confirm the exact cleared version, enabled options, deployment, and local compatibility.
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.
Current vendor materials are product-family evidence for K212383; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K212383 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.
product family · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.
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. Use only the labeled vascular procedures and imaging configuration. Registration, motion, contrast, anatomy, and patient positioning must be checked by the operator; the overlay is not an autonomous device-placement decision.
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 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software, model, and algorithm 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: Use only the labeled vascular procedures and imaging configuration. Registration, motion, contrast, anatomy, and patient positioning must be checked by the operator; the overlay is not an autonomous device-placement decision.
product family · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.
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 system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this system, 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.
K212383
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
5 unlinked candidate evidence records are retained for source review and excluded from this evidence display.
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, 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.
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; packet-unavailable facts: intendedUsers, input, output, limitations, evidenceSummary. Candidate literature and postmarket candidates remain in their existing review state. Automated exact-name discovery found 5 PubMed and 4 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, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, fda decision summary packet, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, anatomy, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamilyContext, workflowRole, implementationCapabilities
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Regulatory record
510(k)
Research record
fda record reviewed
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