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 status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact 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.
FDA source Exact FDA submission Checked 2026-09-05
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K253690
FDA source Exact FDA submission Checked 2026-08-31
Vendor confirmation Exact FDA submission Checked 2026-09-06
No dated, scoped security evidence was reviewed.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
Current training and support terms were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Vendor family environment
The vendor describes lung map and parameter-report workflows with syngo MR and syngo.via requirements.
product family · checked 2026-09-05
That page states the offering is under development and not commercially available; it does not negate FDA clearance or establish U.S. commercial availability.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
FDA review reports nonclinical segmentation testing on 342 images; the training, tuning, and test datasets were separated and included imaging from 0.55T, 1.5T, and 3T systems and participants aged 6-85 years.
FDA source Exact FDA submission Checked 2026-09-05
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
No scoped public price or procurement award was reviewed.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-06
No applicable payer policy was reviewed.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-04
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
Open questions to take to the vendor
Verify security and privacy controls: No dated, scoped security evidence was reviewed.
Verify training: Current training and support terms were not established.
Verify pricing and total cost: No scoped public price or procurement award was reviewed.
Verify reimbursement and coding relevance: No applicable payer policy was reviewed.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: 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.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
23Fields reviewed
10Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
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, pubmed, clinical trials, openfda device recall
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