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Healthcare AI 2026Updated

List of FDA-Cleared AI Radiology Triage Software Vendors

Comprehensive directory of software vendors offering FDA 510(k)-cleared AI solutions for radiology triage — automated worklist prioritization, critical finding detection, and care coordination across CT, X-ray, and MRI modalities.

Available Data Fields

Vendor Name
FDA Clearance Number
Cleared Indications
Imaging Modality
Clinical Area
Integration Method
Headquarters
Deployment Model
Regulatory Pathway
Year of First Clearance

Data Preview

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VendorFDA ClearanceCleared Indications
AidocK233425ICH, PE, Aortic Dissection, C-Spine Fracture + 10 more
Viz.aiDEN180034LVO Stroke, PE, Aortic Dissection, ICH
RapidAIK201596ICH, LVO, CT Perfusion, Aortic Aneurysm
Qure.aiK201501ICH, Midline Shift, Cranial Fracture, Pneumothorax
Annalise.aiK231656Pneumothorax, Pleural Effusion, Pneumoperitoneum, VCF

100+ records available for download.

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FDA-Cleared AI Radiology Triage Software: Market Landscape

The FDA has authorized over 1,100 AI-enabled radiology devices as of early 2026, with triage solutions forming one of the fastest-growing subcategories. These tools automatically analyze imaging studies — primarily non-contrast head CT, chest X-ray, and body CT — to flag critical findings and reprioritize the radiologist worklist in real time.

How AI Triage Changes Radiology Workflow

Traditional radiology worklists operate on a first-in-first-out basis, meaning a tension pneumothorax discovered on a portable chest X-ray may sit behind dozens of routine outpatient studies. AI triage software intercepts DICOM images as they arrive from the scanner, runs inference in seconds, and pushes suspected critical cases to the top of the queue with an alert to the reading radiologist and, in some platforms, directly to the treating clinician.

The measurable impact is significant. Peer-reviewed studies on Viz.ai’s stroke triage platform show patients reaching treatment up to 66 minutes faster when AI alerts are active. Aidoc’s multi-condition CT triage system reported 97% mean sensitivity and 98% mean specificity across 14 cleared indications in its pivotal study.

Regulatory Pathways

510(k) Clearance
The most common pathway. The vendor demonstrates substantial equivalence to a predicate device. The majority of radiology AI triage tools use this route.
De Novo Classification
Used when no predicate exists. Viz.ai’s original LVO stroke triage device was the first AI triage software to receive De Novo authorization in 2018.
Breakthrough Device Designation
Grants priority review. Aidoc and Annalise.ai have both received this designation for triage products.

Key Clinical Areas Covered

Clinical AreaCommon IndicationsExample Vendors
NeurovascularLVO stroke, ICH, midline shiftViz.ai, RapidAI, Qure.ai
PulmonaryPE, pneumothorax, pleural effusionAidoc, Annalise.ai, Viz.ai
CardiovascularAortic dissection, aortic aneurysmAidoc, RapidAI
Trauma / AbdomenRib fracture, liver/spleen injury, bowel obstructionAidoc
MusculoskeletalC-spine fracture, vertebral compression fractureAnnalise.ai, Nanox AI

Evaluating a Triage Vendor

Radiology department chiefs and hospital IT procurement teams typically weigh these factors:

  • Breadth of cleared indications — a platform covering stroke, PE, and trauma simultaneously reduces the number of point solutions to manage.
  • PACS/RIS integration — DICOM-native, HL7/FHIR-compatible solutions minimize deployment friction.
  • Clinical evidence — peer-reviewed sensitivity/specificity data from multi-site trials, not just internal validation.
  • Alert routing — the ability to notify not just radiologists but also stroke teams, trauma surgeons, or intensivists via mobile push or secure messaging.
  • Foundation model architecture — newer platforms (Aidoc CARE™, RapidAI Enterprise) use a single foundation model to detect multiple conditions per scan, reducing compute overhead and integration complexity.

Frequently Asked Questions

Q.How current is this vendor list?

When you request the data, our AI crawls public sources — FDA device databases, vendor websites, press releases — to compile the latest cleared products. This is not a static database; it reflects the most recent publicly available information at the time of your request.

Q.Does this include devices cleared outside the U.S.?

This dataset focuses specifically on FDA-authorized devices (510(k), De Novo, PMA). CE-marked or NMPA-approved devices that lack FDA clearance are not included.

Q.Can I filter by specific clinical indication like PE or stroke?

Yes. Each entry includes the specific cleared indications, so you can filter for vendors covering pulmonary embolism, intracranial hemorrhage, large vessel occlusion, or any other specific finding.

Q.Are OEM/white-label solutions included?

Yes. Some vendors like GE HealthCare and Siemens Healthineers have acquired AI triage companies and offer them under their own brand. These are listed with both the OEM branding and the original technology provider where applicable.

Q.What is the difference between detection and triage clearance?

Detection clearance means the algorithm can identify a finding. Triage clearance additionally authorizes the software to reprioritize the radiology worklist — moving suspected critical cases ahead of routine studies. This dataset focuses on vendors with triage authorization, which carries a higher regulatory bar.