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
The Synapse Lung Nodule AI is a computer-assisted detection software device intended to be used as concurrent reader to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on the lung cancer screening population according to the lung cancer screening protocols. The Synapse Lung Nodule AI requires that both lungs be in the field of view. The Synapse Lung Nodule AI provides adjunctive information such as bounding boxes, segmented contours, and measurement values, and is not intended to be used without the original CT series. The Synapse Lung Nodule AI is also not intended to be used for the differentiation of the detected regions between benign and malignant.
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
- The Synapse Lung Nodule AI is a computer-assisted detection software device intended to be used as concurrent reader to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on the lung cancer screening population according to the lung cancer screening protocols. The Synapse Lung Nodule AI requires that both lungs be in the field of view. The Synapse Lung Nodule AI provides adjunctive information such as bounding boxes, segmented contours, and measurement values, and is not intended to be used without the original CT series. The Synapse Lung Nodule AI is also not intended to be used for the differentiation of the detected regions between benign and malignant.
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
- Intended users
- Radiologist
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Segmentation or contouring
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- CT images or data. Inclusion criteria: Non-contrast chest CT images from the lung cancer screening population; both lungs must be in the field of view; slice thickness less than 3 mm; DICOM format images from Canon, GE, Philips, or Siemens CT scanners
Conservative normalization of explicit wording in an exact-submission source.
- Output and human action
- The device outputs bounding boxes representing nodule location, segmented contours displayed on all slices when the mouse cursor is over the identified nodule, and measurement values including volume, long axis length, short axis length, average axis length, and average HU value for each detected nodule of 4 mm and above. Results are overlaid on the original CT series in the PACS viewer.
Clinical output reported in the exact-submission ACR model card.
- Limitations
- Exclusion criteria: Not intended for use without the original CT series; not intended for differentiation of detected regions between benign and malignant; cases where both lungs are not in the field of view
Limitations and supported-acquisition details reported in the exact-submission ACR model card.
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.
- FDA submission
- K254075
- Modality
- CT/CTA
Imaging modality reported in the exact-submission ACR AI Central model card.
- Anatomy
- Chest/Lung
Anatomy normalized from explicit exact-submission ACR model-card wording.
- Clearance type
- 510(k)
- Decision date
- 2026-05-27
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references DICOM and PACS in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- Research pending
Attach an exact-product deployment and data-flow source.
- Security and privacy
- Vendor documentation pending
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
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.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- Study type: Reader Study. Reference standard: null. Reader-study cases: 300. Readers: 15
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- 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
Reader Study · Adult
exact submission · Tested version: Exact product version not reported; regulatory study summarized for FDA submission K254075 · Independence not establishedK254075
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Economics and lifecycle
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
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
- Reimbursement and coding
- Research pending
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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
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 deployment and data flow: Attach an exact-product deployment and data-flow source.
- Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
- Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
- 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.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Automated sources checkedStatus
2026-09-04Last searched
17Fields reviewed
5Source classes checked
0Unreviewed PubMed leads
0Unreviewed trial leads
0Unreviewed FDA recall leads
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, acr ai central product, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-02.
- K254075 FDA decision source U.S. Food and Drug Administration · 2026-08-31
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Synapse Lung Nodule AI model card (K254075) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
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