Radiology AI Directory

FDA-cleared profile

AmCAD-UO

AmCad BioMed Corporation

AmCAD-UO analyzes pharyngeal and upper-airway ultrasonic images to visualize and quantify airway structures for physician evaluation and monitoring.

Detection and CADeQuantification and segmentationUltrasound workflow
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
AmCAD-UO analyzes pharyngeal and upper-airway ultrasonic images to visualize and quantify airway structures for physician evaluation and monitoring.
FDA source Exact FDA submission Checked 2026-09-03
Intended users
Qualified physicians, sonographers, and other trained ultrasound professionals.
FDA source Exact FDA submission Checked 2026-09-03
Care setting and population
Hospitals, clinics, offices, operating rooms, and point-of-care environments within the cleared applications.
FDA source Exact FDA submission Checked 2026-09-03
Workflow role
Ultrasound acquisition, measurement, analysis, reporting, and release-specific AI assistance.
FDA source Exact FDA submission Checked 2026-09-03
Required input
Live or imported ultrasound data from supported probes, systems, host devices, and applications.
FDA source Exact FDA submission Checked 2026-09-03
Output and human action
Ultrasound images, measurements, calculations, overlays, and reports for clinician review.
FDA source Exact FDA submission Checked 2026-09-03
Limitations
Use only supported upper-airway image inputs and measurements. The output supports physician evaluation and monitoring and is not a stand-alone diagnosis or airway-management decision.
FDA source Exact FDA submission Checked 2026-09-03

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
K180867
FDA source Exact FDA submission Checked 2026-08-31
Modality
Ultrasound
FDA source Exact FDA submission Checked 2026-09-03
Anatomy
Head/Neck
FDA source Exact FDA submission Checked 2026-09-03
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2018-12-28
FDA source Exact FDA submission Checked 2026-08-31
FDA status
FDA-cleared
FDA source Exact FDA submission Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.
FDA source Exact FDA submission Checked 2026-09-03
Deployment and data flow
Ultrasound hardware or software with supported probes, host devices, licensed options, and network configuration.
FDA source Exact FDA submission Checked 2026-09-03
Security and privacy
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified physicians, sonographers, and other trained ultrasound professionals should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
FDA source Exact FDA submission Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use only supported upper-airway image inputs and measurements. The output supports physician evaluation and monitoring and is not a stand-alone diagnosis or airway-management decision.
FDA source Exact FDA submission Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K180867 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. The capability is derived from the exact FDA workflow and still requires local acceptance testing.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Use only supported upper-airway image inputs and measurements. The output supports physician evaluation and monitoring and is not a stand-alone diagnosis or airway-management decision.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Use only supported upper-airway image inputs and measurements. The output supports physician evaluation and monitoring and is not a stand-alone diagnosis or airway-management decision.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. The capability is derived from the exact FDA workflow and still requires local acceptance testing.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary
K180867 reports software, ultrasonic-image processing, measurement, and validation testing for the upper-airway workflow. The public FDA summary does not establish a clinical outcome, sensitivity, or specificity value.
FDA source Exact FDA submission Checked 2026-09-03
Reported sensitivity
Not applicable
Not applicable Not applicable Checked 2026-09-03

Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
Not applicable Not applicable Checked 2026-09-03

Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K180867 FDA performance package for AmCAD-UO

Manufacturer ultrasonic-image processing, measurement, and software validation · Pharyngeal and upper-airway ultrasound images for physician evaluation and monitoring

exact submission · Tested version: AmCAD-UO · Sponsor or vendor study

K180867

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

Efficacy of upper airway ultrasonography in detecting obstructive sleep apnea in the general population.

Peer-reviewed literature candidate identified by exact-name search; full product and version applicability review pending · Head/Neck or related Ultrasound workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

42501873

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy

ClinicalTrials.gov candidate identified by exact-name search; full product and version applicability review pending · Head/Neck or related Ultrasound workflow; exact product and version linkage not established

product family · Tested version: Candidate source; exact FDA submission and product version not established · Independence not established

NCT06154577

Candidate source was found by automated exact-name search; product or version linkage and clinical endpoint were not independently established, so it must not be treated as exact-submission performance evidence.

Source

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
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
Public source Not applicable Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K180867 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
25Fields reviewed
10Source classes checked
1Unreviewed PubMed leads
1Unreviewed trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials were reviewed for identity, indication, users, workflow, limitations, and submitted performance. Current vendor material is labeled product-family context where it does not establish the exact release. PubMed and ClinicalTrials.gov results are retained as candidate evidence with version applicability pending; CMS reimbursement context and exact-identifier openFDA postmarket results were also checked. Pricing, final security architecture, contracted services, enabled options, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 1 PubMed and 1 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, fda decision summary, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-03.

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