FDA-cleared profile
Therenva SAS
Authorized purpose: EndoNaut fuses planning images with live fluoroscopy and provides computerized navigation support for fluoroscopy-guided aneurysm repair, embolization, and peripheral-artery procedures involving the chest, abdomen, pelvis, neck, or lower limbs.
Product overview
Authorized purpose: EndoNaut fuses planning images with live fluoroscopy and provides computerized navigation support for fluoroscopy-guided aneurysm repair, embolization, and peripheral-artery procedures involving the chest, abdomen, pelvis, neck, or lower limbs.
Overview status: Source-reviewed overview
Clinical role: EndoNaut fuses planning images with live fluoroscopy and provides computerized navigation support for fluoroscopy-guided aneurysm repair, embolization, and peripheral-artery procedures involving the chest, abdomen, pelvis, neck, or lower limbs.
Evidence from the reviewed source record: K222070 reports image-fusion, registration, navigation, software, and usability verification for the specified fluoroscopic procedures. The physician must confirm anatomy with contrast angiography and retain responsibility for invasive-device deployment; the FDA package does not establish an autonomous procedural-performance claim.
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 packet states that EndoNaut is indicated for use by Physicians and does not state the dossier's broader staff list.
The replacement uses the packet's listed input data and removes unsupported ultrasound and generic user-input wording.
The replacement uses the packet's output-data feature list.
The replacement uses the packet's explicit judgment and real-time-anatomy checks.
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 K222070; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Current vendor materials are product-family evidence for K222070; 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 K222070; 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 K222070 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. The operator remains responsible for procedural decisions, source-image review, landmark confirmation, and fallback when inputs, tracking, calibration, or output quality are inadequate.
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: The operator remains responsible for procedural decisions, source-image review, landmark confirmation, and fallback when inputs, tracking, calibration, or output quality are inadequate.
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.
K222070
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.
The refreshed discovery snapshot contains 5 PubMed and 4 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 5 PubMed and 4 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, vendor product page, peer reviewed literature, clinical trial registry, 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, modality, anatomy, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse
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
Editorial review
Source-reviewed editorial overlay
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