Authorized purpose: Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and clinicians review the original study.
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: Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and clinicians review the original study.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and clinicians review the original study.
Which images or clinical context are in scope?Modality: CT/CTA Anatomy or clinical context: Chest/Lung Input: Filtered and de-identified DICOM chest and abdominal CT images, received, saved and processed chronologically by series.
Who uses it?Intended users: Hospital networks and appropriately trained medical specialists within the standard-of-care bone-health setting.
What does the software produce?Output: A desktop feed notification for a suspected VCFx case and a compressed, low-quality, grayscale, unannotated preview captioned for prioritization only; the original medical image is not altered.
What is its most important limitation?Key limitation: The preview and notification are informational and not for diagnostic use beyond notification. Clinicians must review the full original images in local PACS with other patient information and professional judgment; the device does not replace diagnosis or disturb standard interpretation.
Clinical takeaway
Clinical role: Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and clinicians review the original study.
Evidence takeaway
Evidence from the reviewed source record: K222692's exact FDA pivotal study evaluated 318 chest and abdominal CT cases at five U.S. sites against ground truth from three senior board-certified radiologists. The study reported observed AUC, sensitivity, specificity and notification-time results; its performance goals were thresholds and are kept separate from the observed values.
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
Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and clinicians review the original study.
Computer-aided triage and notification: a suspect case appears in a desktop feed with an unannotated compressed preview while the original PACS workflow continues.
A desktop feed notification for a suspected VCFx case and a compressed, low-quality, grayscale, unannotated preview captioned for prioritization only; the original medical image is not altered.
The preview and notification are informational and not for diagnostic use beyond notification. Clinicians must review the full original images in local PACS with other patient information and professional judgment; the device does not replace diagnosis or disturb standard interpretation.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Uses PACS and radiology-workstation workflow with DICOM acquisition, filtered/de-identified transfer to cloud processing, and a desktop feed/non-diagnostic viewer that sends the clinician back to local PACS for full-image review.
The exact FDA description uses an Aidoc Hospital Server/Orchestrator for acquisition, an Aidoc Cloud Server for processing and an Aidoc Desktop Application for workflow integration; the described server stack includes a DICOM module and de-identification before cloud processing.
FDA source
Exact FDA submission
Checked 2026-09-07
This is the submission-era architecture; current tenant, hosting, security and contract terms require vendor confirmation.
Cloud architecture and de-identification language do not establish formal security controls for a current installed configuration.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Exact DICOM triage and cloud-processing path
The exact FDA record describes Aidoc Hospital Server acquisition, de-identification and filtering, Aidoc Cloud Server processing, and a desktop feed/non-diagnostic viewer that prompts review of original images in local PACS.
Aidoc's current neuro solution page lists vertebral compression fractures among CT algorithms in its Full Brain AI Solution and describes facility-level CT processing with deep integration and aiOS orchestration.
product family · checked 2026-09-07
Current family platform context does not establish the exact K222692 release, configuration or contractual interfaces.
Current Aidoc workstation and enterprise integrations
Aidoc's current radiology platform page describes a workstation Widget with key images and AI-result summaries, direct worklist marking, and integrations with PACS, EHR, scheduling and reporting.
product family · checked 2026-09-07
Family-level buyer workflow context only; exact K222692 compatibility requires site and vendor confirmation.
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
K222692's exact FDA pivotal study evaluated 318 chest and abdominal CT cases at five U.S. sites against ground truth from three senior board-certified radiologists. The study reported observed AUC, sensitivity, specificity and notification-time results; its performance goals were thresholds and are kept separate from the observed values.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-07
No public exact-submission price or procurement terms were reviewed.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-07
CMS policy research was not performed by this worker; no coverage conclusion is made.
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
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
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 security and privacy controls: Cloud architecture and de-identification language do not establish formal security controls for a current installed configuration.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: No public exact-submission price or procurement terms were reviewed.
Verify reimbursement and coding relevance: CMS policy research was not performed by this worker; no coverage conclusion is made.
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.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
26Fields reviewed
13Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads
The stored PubMed and ClinicalTrials candidate metadata were screened in the exact stored order; this was metadata triage, not full-text paper or registry-record review, and no candidate was promoted. The stored recall query returned no records, so no event was promoted and no absence claim is made. The current discovery snapshot contains 20 PubMed and 6 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, vendor product page, vendor clinical study, vendor press release, literature index, trial registry, stored candidate metadata, stored recall candidates, 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 history9 sources - 3 history items
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