ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for syngo.CT Lung CAD; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-09FDA-cleared profile
syngo.CT Lung CAD
Siemens Healthcare GmbH
Authorized purpose: Adjunctive CAD assistance to alert radiologists to regions of interest that may otherwise be overlooked during chest MDCT review; concurrent first-reader or second-reader use is permitted, followed by full radiologist review.
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: Adjunctive CAD assistance to alert radiologists to regions of interest that may otherwise be overlooked during chest MDCT review; concurrent first-reader or second-reader use is permitted, followed by full radiologist review.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Adjunctive CAD assistance to alert radiologists to regions of interest that may otherwise be overlooked during chest MDCT review; concurrent first-reader or second-reader use is permitted, followed by full radiologist review.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Pulmonary nodules in the thorax, including solid and subsolid (part-solid and ground-glass) nodules. Input: Chest MDCT from multivendor scanners, with 16 or more detector rows; the scan must cover the entire thorax from lung apices to bases, with cranio-caudal or caudal-cranial direction, 100-140 kVp, up to and including 2.5 mm slice thickness, and no reconstruction gaps. The packet describes Siemens, GE, Philips, and Toshiba scanner data and typical validated kernels.
- Who uses it? Intended users: Radiologists and trained professionals evaluating the CAD output.
- What does the software produce? Output: A list of nodule candidate locations sent to a visualization application or rendering component, which generates output image series with CAD marks superimposed on the input thoracic CT images.
- What is its most important limitation? Key limitation: Validated nodule scope is solid nodules at least 3 mm and less than 30 mm and subsolid nodules at least 5 mm and less than 30 mm, including central or peripheral and round or irregular contours. Intravenous contrast is not established as a supported characteristic in the study comparison; the packet states full radiologist review remains required and the hosting application supplies the user interface.
Clinical takeaway
Clinical role: Adjunctive CAD assistance to alert radiologists to regions of interest that may otherwise be overlooked during chest MDCT review; concurrent first-reader or second-reader use is permitted, followed by full radiologist review.
Evidence takeaway
Evidence from the reviewed source record: The pivotal retrospective reader study had 20 readers review all 232 cases in both second-reader and concurrent-first-reader workflows; five expert radiologists reviewed consolidated marks. Reader-majority truthing with expert adjudication identified 143 cases with at least one true nodule and 89 without true nodules. All reported analysis endpoints were satisfactorily met and all readers showed significant improvement in detection of solid, part-solid, and ground-glass nodules in both workflows; no numeric sensitivity, specificity, AUC, PPV, NPV, or reader-delta result is provided in the packet text.
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
- Adjunctive CAD assistance to alert radiologists to regions of interest that may otherwise be overlooked during chest MDCT review; concurrent first-reader or second-reader use is permitted, followed by full radiologist review.
- Intended users
- Radiologists and trained professionals evaluating the CAD output.
- Care setting and population
- Screening and diagnostic chest CT reading workflows.
- Workflow role
- Concurrent first-reader support followed by full review, or second-reader support after the radiologist's initial read; the algorithm alerts to ROI candidates and does not provide its own display UI.
- Required input
- Chest MDCT from multivendor scanners, with 16 or more detector rows; the scan must cover the entire thorax from lung apices to bases, with cranio-caudal or caudal-cranial direction, 100-140 kVp, up to and including 2.5 mm slice thickness, and no reconstruction gaps. The packet describes Siemens, GE, Philips, and Toshiba scanner data and typical validated kernels.
- Output and human action
- A list of nodule candidate locations sent to a visualization application or rendering component, which generates output image series with CAD marks superimposed on the input thoracic CT images.
- Limitations
- Validated nodule scope is solid nodules at least 3 mm and less than 30 mm and subsolid nodules at least 5 mm and less than 30 mm, including central or peripheral and round or irregular contours. Intravenous contrast is not established as a supported characteristic in the study comparison; the packet states full radiologist review remains required and the hosting application supplies the user interface.
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
- The algorithm sends candidate locations to a hosting visualization application such as syngo MM Oncology or a rendering component; syngo MM Oncology is deployed on syngo.via, which displays the CAD marks. The device has no standalone UI, and specific local PACS or RIS compatibility is not established.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- 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.
Evidence
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 pivotal retrospective reader study had 20 readers review all 232 cases in both second-reader and concurrent-first-reader workflows; five expert radiologists reviewed consolidated marks. Reader-majority truthing with expert adjudication identified 143 cases with at least one true nodule and 89 without true nodules. All reported analysis endpoints were satisfactorily met and all readers showed significant improvement in detection of solid, part-solid, and ground-glass nodules in both workflows; no numeric sensitivity, specificity, AUC, PPV, NPV, or reader-delta result is provided in the packet text.
- 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.
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 K203258 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 K203258. 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 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 K203258 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
17Fields 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, fda decision summary, acr ai central product, 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 K203258: syngo.CT Lung CAD
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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syngo.CT Lung CAD model card (K203258)
Scope: anatomy
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
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openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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openFDA exact recall query for K203258
Scope: postmarketSafety
Research history
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K203258 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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