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
a2z-Unified-Triage
A2z Radiology Ai, Inc.
Authorized purpose: Adult abdominal/pelvic CT triage for acute cholecystitis, acute pancreatitis, unruptured AAA, acute diverticulitis, free air, hydronephrosis, and small-bowel obstruction.
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: Adult abdominal/pelvic CT triage for acute cholecystitis, acute pancreatitis, unruptured AAA, acute diverticulitis, free air, hydronephrosis, and small-bowel obstruction.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Adult abdominal/pelvic CT triage for acute cholecystitis, acute pancreatitis, unruptured AAA, acute diverticulitis, free air, hydronephrosis, and small-bowel obstruction.
- Which images or clinical context are in scope? Modality: CT/CTA Anatomy or clinical context: Abdomen and Pelvis Input: Abdominal/pelvic DICOM CT images with or without contrast from adults aged 22 and older.
- Who uses it? Intended users: Appropriately trained medical specialists in hospital networks and clinical settings.
- What does the software produce? Output: A JSON object with binary present/absent classification for each of the seven findings and DICOM instance UIDs for key images in positive cases, enabling client systems to generate notifications and prioritize the worklist.
- What is its most important limitation? Key limitation: Not a diagnostic device; full original images require clinician review. FDA performance was based on 2-5 mm CT studies and the cleared PCCP requires locked, pre-release validation for modifications; hosting and local compatibility details are not established.
Clinical takeaway
Clinical role: Adult abdominal/pelvic CT triage for acute cholecystitis, acute pancreatitis, unruptured AAA, acute diverticulitis, free air, hydronephrosis, and small-bowel obstruction.
Evidence takeaway
Evidence from the reviewed source record: FDA standalone assessment used 675 analytic cases from 643 unique patients across 12 sites, with 2+1 U.S. board-certified radiologists establishing ground truth. Primary acceptance differed by product-code condition: QFM findings required AUC greater than 0.95, while QAS findings required sensitivity and specificity above 80%. FDA reported QFM AUCs of 0.985 acute cholecystitis, 0.994 acute pancreatitis, 0.995 unruptured AAA, 0.995 acute diverticulitis, and 0.976 hydronephrosis; QAS high-sensitivity operating points were SBO Se 94.9%/Sp 91.7% and balanced free-air Se 89.3%/Sp 88.6%. The comparison table reports mean triage turnaround 58.39 seconds (95% CI 56.11-60.68), median 55.02 seconds, and 95th percentile 90.36 seconds.
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
- Adult abdominal/pelvic CT triage for acute cholecystitis, acute pancreatitis, unruptured AAA, acute diverticulitis, free air, hydronephrosis, and small-bowel obstruction.
- Intended users
- Appropriately trained medical specialists in hospital networks and clinical settings.
- Care setting and population
- Hospital or other clinical settings with DICOM-compliant CT imaging and IT infrastructure for adults aged 22 and older.
- Workflow role
- Multi-condition binary triage and notification support in parallel with standard of care; the output does not replace diagnostic review.
- Required input
- Abdominal/pelvic DICOM CT images with or without contrast from adults aged 22 and older.
- Output and human action
- A JSON object with binary present/absent classification for each of the seven findings and DICOM instance UIDs for key images in positive cases, enabling client systems to generate notifications and prioritize the worklist.
- Limitations
- Not a diagnostic device; full original images require clinician review. FDA performance was based on 2-5 mm CT studies and the cleared PCCP requires locked, pre-release validation for modifications; hosting and local compatibility details are not established.
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
- Supports direct integration with healthcare-facility systems or third-party healthcare technology platforms; receives abdominal/pelvic CT from clinical imaging systems and returns JSON/DICOM-UID results to client systems. Both cloud-based and on-premises deployment are described; exact interfaces and versions are not established.
- Deployment and data flow
- Cloud-based and on-premises deployment are explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.
Deployment mode explicitly reported in the exact-submission ACR model card; hosting region 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.
Deployment model
Cloud-based and on-premises deployment are explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.
exact submission · checked 2026-09-01ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for a2z-Unified-Triage; 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 standalone assessment used 675 analytic cases from 643 unique patients across 12 sites, with 2+1 U.S. board-certified radiologists establishing ground truth. Primary acceptance differed by product-code condition: QFM findings required AUC greater than 0.95, while QAS findings required sensitivity and specificity above 80%. FDA reported QFM AUCs of 0.985 acute cholecystitis, 0.994 acute pancreatitis, 0.995 unruptured AAA, 0.995 acute diverticulitis, and 0.976 hydronephrosis; QAS high-sensitivity operating points were SBO Se 94.9%/Sp 91.7% and balanced free-air Se 89.3%/Sp 88.6%. The comparison table reports mean triage turnaround 58.39 seconds (95% CI 56.11-60.68), median 55.02 seconds, and 95th percentile 90.36 seconds.
- Reported sensitivity
- Acute Cholecystitis: 96.1% [89.2-98.7%], Acute Pancreatitis: 98.0% [92.9-99.4%], Unruptured AAA: 100.0% [95.2-100.0%, Acute Diverticulitis: 98.7% [92.9-99.8%], Free Air: 89.3% [82.2-93.8%], Hydronephrosis: 89.7% [82.1-94.3%], Small Bowel Obstruction: 94.9% [88.7-97.8%]
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- Acute Cholecystitis: 89.3% [86.6-91.5%], Acute Pancreatitis: 87.8% [84.9-90.3%], Unruptured AAA: 86.3% [83.3-88.8%], Acute Diverticulitis: 89.3% [86.6-91.5%], Free Air: 88.6% [85.7-91.0%], Hydronephrosis: 92.9% [90.5-94.7%], Small Bowel Obstruction: 91.7% [89.1-93.7%]
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
a2z-Unified-Triage regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K252366
- Samplen=675
- Sites12
- IndependenceIndependence not established
K252366
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 K252366 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 K252366. 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 K252366 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
2026-09-19Last searched
26Fields 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 K252366: a2z-Unified-Triage
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
a2z-Unified-Triage model card (K252366)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, deployment, 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 K252366
Scope: postmarketSafety
Research history
-
K252366 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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