FDA-cleared profile
Siemens Healthineers AG
Authorized purpose: LungMaps processes one or more 2D lung MRI time series to support radiologist interpretation of ventilation and perfusion maps; it is not the sole source for diagnosis.
Product overview
Authorized purpose: LungMaps processes one or more 2D lung MRI time series to support radiologist interpretation of ventilation and perfusion maps; it is not the sole source for diagnosis.
Overview status: Source-reviewed overview
Clinical role: LungMaps processes one or more 2D lung MRI time series to support radiologist interpretation of ventilation and perfusion maps; it is not the sole source for diagnosis.
Evidence from the reviewed source record: Non-clinical testing used 342 test images; the average Dice score was 0.91, the average Hausdorff distance was 4.1 pixels (SD = 3.9), the average surface distance was 0.8 pixels (SD = 0.8), the average absolute volumetric difference was 2.5 (SD = 159.5), and the relative volumetric difference was 3.2 (SD = 21.4). The representative dataset included 0.55T, 1.5T, and 3T MRI systems and subjects aged 6 to 85 years; no clinical tests were conducted for the subject device.
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 packet states that the device is intended for healthcare professionals and does not establish a more specific user role.
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.
The exact intended-use statement provides the radiologist-interpretation and diagnosis 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 syngo versions and local implementation requirements need confirmation.
No dated, scoped security evidence was reviewed.
Current training and support terms were not established.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
The vendor describes lung map and parameter-report workflows with syngo MR and syngo.via requirements.
product family ยท checked 2026-09-05That page states the offering is under development and not commercially available; it does not negate FDA clearance or establish U.S. commercial availability.
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.
The exact FDA summary reports the test-set size, segmentation metrics, field strengths, age range, and absence of clinical tests.
Segmentation Dice is not a diagnostic sensitivity measure.
No diagnostic specificity was established.
0.91 coefficient
K253690
No clinical tests were conducted for the submitted device according to the FDA summary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No scoped public price or procurement award was reviewed.
No applicable payer policy was reviewed.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
No stored PubMed or ClinicalTrials candidates. Native-submission recall candidate snapshot was zero. The current discovery snapshot contains 0 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, acr ai central product, fda decision material, vendor product page, literature index, trial registry, 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: identity, clinicalUse, modality, anatomy, input, output, limitations, integration, deployment, evidenceSummary, evidenceMetrics, purpose, intendedUsers
Scope: regulatoryIdentity, modalityContext
Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamilyWorkflow, implementationCapabilities
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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