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.
FDA-cleared profile
BriefCase-Quantification
Aidoc Medical, Ltd.
Authorized purpose: Assist appropriately trained medical specialists by providing the maximum abdominal aortic axial diameter from contrast-enhanced CT exams that include the abdominal aorta in adults or transitional adolescents aged 18 years and older; evaluate normal and aneurysmal abdominal aortas, not postoperative aortas, and do not use results alone for clinical decisions.
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: Assist appropriately trained medical specialists by providing the maximum abdominal aortic axial diameter from contrast-enhanced CT exams that include the abdominal aorta in adults or transitional adolescents aged 18 years and older; evaluate normal and aneurysmal abdominal aortas, not postoperative aortas, and do not use results alone for clinical decisions.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Assist appropriately trained medical specialists by providing the maximum abdominal aortic axial diameter from contrast-enhanced CT exams that include the abdominal aorta in adults or transitional adolescents aged 18 years and older; evaluate normal and aneurysmal abdominal aortas, not postoperative aortas, and do not use results alone for clinical decisions.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Abdominal aorta Input: Filtered DICOM images from contrast-enhanced CT exams including the abdominal aorta, in adults or transitional adolescents aged 18 years and older; relevant series are processed chronologically.
- Who uses it? Intended users: Appropriately trained medical specialists
- What does the software produce? Output: A preview image annotated with the maximum axial abdominal-aortic diameter measurement, forwarded to an image-review application and PACS; the original unmarked series remains available, and the preview is labeled unofficial, not final, and for review by a radiologist.
- What is its most important limitation? Key limitation: Not intended to evaluate postoperative aortas. The measurement is unofficial and not final, must be reviewed against full images and other clinical information by a radiologist, and must not be used standalone or to preclude clinical assessment; final approved measurements come from the official radiology report. The FDA packet does not establish a specific current PACS, RIS, EHR, or deployment configuration beyond the described cloud-server workflow.
Clinical takeaway
Clinical role: Assist appropriately trained medical specialists by providing the maximum abdominal aortic axial diameter from contrast-enhanced CT exams that include the abdominal aorta in adults or transitional adolescents aged 18 years and older; evaluate normal and aneurysmal abdominal aortas, not postoperative aortas, and do not use results alone for clinical decisions.
Evidence takeaway
Evidence from the reviewed source record: FDA K230534 reports a retrospective, blinded, multicenter study of 160 CT cases from six US academic and community clinical sites, with ground truth determined by three US board-certified radiologists. The primary endpoint mean absolute error was 1.95 mm (95% CI 1.59-2.32 mm) and met the prespecified performance goal. The validation cohort mean age was 66.8 years, and scanner counts were Siemens 52, GE 46, Philips 39, and Toshiba 23.
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
- Assist appropriately trained medical specialists by providing the maximum abdominal aortic axial diameter from contrast-enhanced CT exams that include the abdominal aorta in adults or transitional adolescents aged 18 years and older; evaluate normal and aneurysmal abdominal aortas, not postoperative aortas, and do not use results alone for clinical decisions.
- Intended users
- Appropriately trained medical specialists
- Care setting and population
- Clinical radiology workflow; the FDA validation used six US academic and community clinical sites but does not establish a required facility type
- Workflow role
- Parallel measurement/quantification adjunct that provides a preview of the maximum axial abdominal-aortic diameter for PACS review; the radiologist reviews full images and the official report remains final.
- Required input
- Filtered DICOM images from contrast-enhanced CT exams including the abdominal aorta, in adults or transitional adolescents aged 18 years and older; relevant series are processed chronologically.
- Output and human action
- A preview image annotated with the maximum axial abdominal-aortic diameter measurement, forwarded to an image-review application and PACS; the original unmarked series remains available, and the preview is labeled unofficial, not final, and for review by a radiologist.
- Limitations
- Not intended to evaluate postoperative aortas. The measurement is unofficial and not final, must be reviewed against full images and other clinical information by a radiologist, and must not be used standalone or to preclude clinical assessment; final approved measurements come from the official radiology report. The FDA packet does not establish a specific current PACS, RIS, EHR, or deployment configuration beyond the described cloud-server workflow.
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 device runs as a Linux-based server in a cloud environment, receives filtered DICOM images, transfers analysis to an image-review desktop application, and forwards results to a PACS destination for medical-specialist review. Exact PACS products, interfaces, versions, hosting region, and current data flow are not established.
- Deployment and data flow
- On-cloud
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.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for BriefCase-Quantification; 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
- FDA K230534 reports a retrospective, blinded, multicenter study of 160 CT cases from six US academic and community clinical sites, with ground truth determined by three US board-certified radiologists. The primary endpoint mean absolute error was 1.95 mm (95% CI 1.59-2.32 mm) and met the prespecified performance goal. The validation cohort mean age was 66.8 years, and scanner counts were Siemens 52, GE 46, Philips 39, and Toshiba 23.
- 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.
BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K230534
- Samplen=160
- Sites6
- IndependenceIndependence not established
K230534
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 K230534 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 K230534. 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 K230534 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
21Fields 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 K230534: BriefCase-Quantification
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) model card (K230534)
Scope: careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K230534
Scope: postmarketSafety
Research history
-
K230534 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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