Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
Synapse Lung Nodule AI
Fujifilm Corporation
Authorized purpose: Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Chest/lungs; pulmonary nodules Input: Non-contrast chest CT in DICOM format, with both lungs in the field of view and slice thickness less than 3 mm; the comparison matrix lists Canon, GE, Philips, and Siemens CT systems.
- Who uses it? Intended users: Radiologist
- What does the software produce? Output: Pulmonary-nodule bounding boxes, segmented contours, and measurements including volume, long-axis length, short-axis length, average-axis length, and average Hounsfield-unit value, displayed over the original CT series in a PACS viewer.
- What is its most important limitation? Key limitation: Both lungs must be in the field of view; the device is not intended for use without the original CT series or to differentiate detected regions as benign or malignant. It is an adjunctive concurrent reader, not a substitute for the original study and radiologist interpretation.
Clinical takeaway
Clinical role: Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
Evidence takeaway
Evidence from the reviewed source record: The FDA packet reports a retrospective MRMC study and standalone evaluation on 300 low-dose chest CT exams from three geographically distinct US regions: 100 with at least one nodule and 200 controls; ground truth was a consensus of three board-certified thoracic radiologists and 15 readers participated. MRMC AUROC increased from 0.768 unaided to 0.835 aided (difference 0.067, p<0.001), LROC from 0.723 to 0.800 (difference 0.076, p<0.001), and reading time fell by 0.76 minutes. Standalone nodule-detection sensitivity was 78.3% (95% CI 71.0-84.8), false-positive rate was 0.76 per case (95% CI 0.64-0.90), and 3D nodule-segmentation Dice was 0.81 (95% CI 0.79-0.83).
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
- Intended users
- Radiologist
- Care setting and population
- Lung cancer screening workflow
- Workflow role
- Concurrent-reader and post-processing detection support; results are overlaid for radiologist review
- Required input
- Non-contrast chest CT in DICOM format, with both lungs in the field of view and slice thickness less than 3 mm; the comparison matrix lists Canon, GE, Philips, and Siemens CT systems.
- Output and human action
- Pulmonary-nodule bounding boxes, segmented contours, and measurements including volume, long-axis length, short-axis length, average-axis length, and average Hounsfield-unit value, displayed over the original CT series in a PACS viewer.
- Limitations
- Both lungs must be in the field of view; the device is not intended for use without the original CT series or to differentiate detected regions as benign or malignant. It is an adjunctive concurrent reader, not a substitute for the original study and radiologist interpretation.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Retrieves DICOM images from PACS and returns nodule information to PACS, specifically Synapse PACS K190232, as an add-on with FUJIFILM hosting applications. The comparison matrix requires a PACS or DICOM-capable image viewer.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Result destination
PACS is explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Synapse Lung Nodule AI; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
Performance 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.
- Evidence summary
- The FDA packet reports a retrospective MRMC study and standalone evaluation on 300 low-dose chest CT exams from three geographically distinct US regions: 100 with at least one nodule and 200 controls; ground truth was a consensus of three board-certified thoracic radiologists and 15 readers participated. MRMC AUROC increased from 0.768 unaided to 0.835 aided (difference 0.067, p<0.001), LROC from 0.723 to 0.800 (difference 0.076, p<0.001), and reading time fell by 0.76 minutes. Standalone nodule-detection sensitivity was 78.3% (95% CI 71.0-84.8), false-positive rate was 0.76 per case (95% CI 0.64-0.90), and 3D nodule-segmentation Dice was 0.81 (95% CI 0.79-0.83).
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Synapse Lung Nodule AI regulatory performance study summary
- DesignReader Study
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K254075
- IndependenceIndependence not established
K254075
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K254075 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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
- The exact-identifier FDA recall query returned no native recall record for K254075. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K254075 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
23Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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 summary, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
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FDA K254075: Synapse Lung Nodule AI
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Synapse Lung Nodule AI model card (K254075)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K254075
Scope: postmarketSafety
Research history
-
K254075 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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