FDA-cleared profile
BodyVision Medical Ltd.
The LungVision System enables users to segment previously acquired 3D CT datasets and overlay and register those segmented datasets with fluoroscopic live X-ray images of the same anatomy to support catheter or device navigation during pulmonary procedures.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
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.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
This is the interface boundary described in the exact FDA package; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.
This is the release-level boundary described in the exact FDA package; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence.
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.
This is buyer-facing monitoring guidance derived from the exact cleared or authorized scope; it is not a claim that the FDA package provides a live monitoring service.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K240943 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared or authorized release includes them.
The FDA package describes an on-site main unit, tablet, router, board, and software integrated with fluoroscopic imaging systems and external displays; current hosting, service, availability, security, and site configuration remain unverified.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA package describes segmentation of 3D CT data, registration to live fluoroscopic X-ray, integration with fluoroscopic imaging systems and external displays, DICOM import, and a main-unit, tablet, router, and board system.
exact submission · checked 2026-09-04Test 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. Use is limited to the labeled pulmonary procedure, anatomy, supported imaging configuration, and professional review; navigation output does not replace clinical judgment.
exact submission · checked 2026-09-04Define 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 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor K240943 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 is limited to the labeled pulmonary procedure, anatomy, supported imaging configuration, and professional review; navigation output does not replace clinical judgment.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. pulmonary procedure image-navigation software limits remain submission-specific.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.
Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, study design, and source if separately verified.
Registration accuracy in 500 simulated cases based on human CT scans.
Tested version: LungVision System configuration described in K240943Registration accuracy in 93 laboratory cases in a patient-simulated rigid lung model.
Tested version: LungVision System configuration described in K240943Registration accuracy in 191 cases based on human CT and CBCT scans from real procedures.
Tested version: LungVision System configuration described in K240943FDA 510(k) or PMA decision evidence and product verification or approval material described in the exact submission. · Lungs; bronchial airways; pulmonary procedures
exact submission · Tested version: LungVision System configuration described in K240943 · Sponsor or vendor studyK240943
The FDA summary describes simulated, rigid-model, and CBCT registration testing; the reported means are not a product-wide clinical-outcome or navigation-success claim.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared or authorized 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 StatesThis is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.
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.
Seven PubMed records and two trial records were screened. Product-naming records concern LungVision generally, a first-generation system, or study-period configurations without linkage to the K240943 AI-Tomo configuration; all nine records are quarantined and none is promoted. The current discovery snapshot contains 7 PubMed and 2 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, fda pma record, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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