Our radiologists are overwhelmed by the volume of X-rays to review. Who offers FDA-cleared AI triage software for medical imaging?

Several prominent medical imaging AI vendors offer FDA-cleared computer-assisted triage and notification software (CADt) specifically designed to prioritize acute or critical findings on X-rays (predominantly chest X-rays for conditions like pneumothorax, pleural effusion, and lung nodules).

Key companies with FDA clearances in this space include:

• Aidoc: Offers comprehensive enterprise AI solutions, including triage and notification algorithms for chest X-ray abnormalities to flag critical acute patient cases for rapid review.
• Lunit: Known for its Lunit INSIGHT CXR suite, which received FDA 510(k) clearance for triage and notification software targeting critical emergency chest X-ray findings.
• Annalise.ai: Provides extensive chest X-ray and CT triage solutions with multiple FDA clearances for flagging urgent and critical abnormalities.
• Oxipit: Offers Oxipit QXR , an AI application for chest radiography that includes autonomous reporting capabilities as well as workflow triage support.
• Bering Ltd.: Received FDA 510(k) clearance for BraveCX , an AI-powered chest X-ray triage solution focused on prioritizing emergency cases such as pneumothorax and pleural effusion.
• Nanox AI (formerly Zebra Medical Vision): Historically secured the first-of-its-kind FDA clearance for chest X-ray pneumothorax triage (HealthPNX ) and continues to develop population health and workflow prioritization tools.

If you'd like, I can provide details on:

• Integration requirements (PACS/DICOM workflow compatibility)
• Specific clinical findings prioritized by each platform (e.g., pneumothorax vs. nodule detection)
• Deployment models (cloud vs. on-premise)

Let me know how you would like to narrow down your evaluation.

Yes. There are several FDA-cleared AI tools specifically intended to triage/prioritize medical images, including X-rays. The FDA classifies these under “radiological computer-assisted triage and notification software,” which is designed to prioritize time-sensitive studies for review rather than replace the radiologist.

Leading options for X-ray workflow

• Lunit — Lunit INSIGHT CXR Triage. FDA-cleared in 2021 (K211733) for chest X-ray triage. It is specifically designed to prioritize chest radiographs based on suspected abnormalities.
• Qure.ai — qXR / qXR-based products. Qure has multiple FDA-cleared chest-X-ray products, including qXR-BT and products for pneumothorax, cardiomegaly and lung nodules; its qER line also addresses emergency imaging triage.
• Aidoc — BriefCase-Triage. Aidoc has a broad FDA-cleared AI triage platform, although its strongest differentiation is currently acute CT findings rather than routine X-ray volume. FDA records show multiple 2025–26 clearances under the radiological triage category.
• Viz.ai — Viz platform. FDA-cleared triage products include Viz ICH and Viz SDH. These are primarily focused on acute neurovascular CT rather than general X-ray queues.
• Gleamer — BoneView. FDA-cleared for musculoskeletal X-ray analysis and useful when the bottleneck involves fracture detection rather than general chest-X-ray prioritization.
• AZmed — Rayvolve. FDA-cleared radiology AI, including musculoskeletal X-ray applications.

If your specific problem is an overloaded X-ray worklist

I'd put Lunit INSIGHT CXR Triage and Qure.ai qXR at the top of the evaluation list for a hospital primarily dealing with high-volume chest X-rays. Their use case is closer to what you described—automatically identifying potentially urgent/abnormal radiographs so they can be moved higher in the radiologist's queue—than the stroke-focused CT products from Viz.ai or many of Aidoc's acute-care algorithms.

One important distinction: “FDA-cleared” does not mean the FDA has validated that the software reduces your radiologists' workload or turnaround time in your particular environment. The clearance applies to the specified intended use. I'd therefore evaluate sensitivity for your target findings, false-positive rate, integration with your PACS/RIS/worklist, latency, and evidence of real-world turnaround-time impact.

If you tell me what kinds of X-rays are overwhelming you (chest, ED trauma, fractures, all plain film) and roughly how many studies/day, I can narrow this to the 3–5 vendors most worth putting through an RFP and compare their FDA indications, pricing model, PACS integration, and clinical evidence.

Several medical technology companies offer FDA-cleared AI computer-assisted triage and notification (CADt) software specifically designed to prioritize urgent or critical findings on X-rays (such as pneumothorax or pleural effusion) and push them to the top of a radiologist's worklist.

Key Providers of FDA-Cleared X-ray Triage Software

Note: Regulatory clearance applies to specific software versions and targeted clinical indications; healthcare institutions should verify exact 510(k) parameters directly with each vendor prior to PACS integration.

If you'd like, I can provide:

• Specific clinical accuracy data for these solutions
• Details on PACS/RIS integration requirements
• Information on reimbursement codes for radiology AI triage

Yes. If your bottleneck is plain-film X-rays, particularly chest X-rays, several vendors have FDA-cleared AI specifically designed to prioritize potentially urgent studies for radiologist review.

The FDA's relevant device category is “radiological computer-assisted triage and notification software” (QAS/QFM). FDA describes these as software that uses image analysis/AI to identify or prioritize time-sensitive imaging for review; they are Class II devices and do not replace the radiologist's diagnostic interpretation.

Which I'd investigate first

For a radiology department overwhelmed by X-ray volume, I'd put these three at the top of the evaluation:

1. Annalise.ai — particularly compelling if you want broad CXR triage rather than a single finding. Its current solution advertises five FDA-cleared CXR findings and integration with PACS/RIS.
2. Lunit — a mature, specifically chest-X-ray-focused triage product with FDA clearance dating to 2021.
3. Qure.ai — worth evaluating if broad CXR abnormality coverage is the priority; its 2026 FDA clearance expanded qXR-Detect substantially.

Aidoc is especially worth considering if you want a broader enterprise radiology AI/triage platform, rather than a solution centered only on X-rays. FDA records show multiple recent BriefCase-Triage clearances, including one decided in May 2026.

One important distinction: “FDA-cleared” doesn't necessarily mean the product is cleared for every X-ray abnormality or every workflow you're considering. The exact 510(k) indication matters. For procurement, I'd compare specific FDA indications, sensitivity/false-positive rates, PACS/RIS integration, latency, worklist behavior, and evidence of reduced turnaround time.

If you tell me whether you're dealing primarily with chest X-rays, MSK X-rays, or all radiographs, I can narrow this to the best 3–5 options and compare their FDA indications and clinical evidence.

Yes. There are several vendors with FDA-cleared AI designed to triage/prioritize medical images, including chest X-rays. The FDA classifies these as radiological computer-assisted triage/prioritization software; importantly, they generally prioritize cases for human review rather than replace the radiologist.

Notable FDA-cleared options

The FDA's current database shows a fairly broad ecosystem of cleared radiology-triage vendors, including Aidoc, Annalise, Avicenna.AI, AZmed, DeepHealth, Envisionit DeepAI, Lunit, MedCognetics, Qure.ai and others.

If your bottleneck is specifically X-ray volume

I'd put Lunit, Qure.ai, and Annalise near the top of the evaluation list if you're dealing predominantly with plain-film chest X-rays, while Aidoc is particularly interesting if the problem extends across CT and other modalities as well.

One important distinction: FDA clearance doesn't mean all of these products have the same clinical scope. For example, Lunit's cleared CXR Triage indication is specifically for prioritizing adult chest X-rays with suspected pneumothorax and/or pleural effusion, whereas Qure.ai's newer qXR-Detect covers a substantially broader set of chest-X-ray findings.

If you tell me what X-rays are overwhelming your radiologists (chest, MSK, trauma, etc.) and roughly how many studies/day, I can narrow this to the 3–5 vendors most suitable for your workflow, including PACS/RIS integration, turnaround time, evidence, and pricing considerations.

Here are top web results for exploring this topic:

Threads·https://www.threads.com**Radiologists** are being left alone to evaluate AI imaging tools with ...The FDA has now cleared more than 1,500 AI-enabled medical devices. Just over 76% of them are radiology and imaging tools. Medical imaging is where AI actually got deployed at scale, sitting next to a Radiology Business·https://radiologybusiness.com**Radiology** Partners petitions FDA for greater clarity around imaging ...As a result, downstream users such as radiologist bear “substantial responsibility” for determining whether these models are appropriate for their intended use. Models introduced without premarket rev AuntMinnie·https://www.auntminnie.com Most FDA-cleared AI medical devices not tested on patient outcomes Over three out of four FDA-cleared AI devices are used in radiology. Ordóñez said radiology has the thinnest prospective evidence base of any major specialty, with registered trials for 0.3% of its cl University of Maryland Institute for Health Computing·https://ihc.umd.edu**Radiology's AI** Reality Check UM-IHC's Florence Doo explains how artificial intelligence is reshaping clinical radiology—and why patient safety, accountability and trust must keep pace. For clinical radiologists, artificial intell AZmed·https://www.azmed.co News in AI Radiology - AZmed AZmed has received the CE mark for AZnod, designed to detect and characterize pulmonary nodules on CT scans. AZnod is the first AI tool for CT within AZmed's Rayscan product line, extending the firm's YouTube·https://www.youtube.com Doctors fooled by AI deepfake X-rays, study finds - YouTube Could you tell the difference between a real X-ray and one created by artificial intelligence? According to new research, even experienced radiologists sometimes can't. A new study is raising concerns Boston 25 News·https://www.boston25news.com How artificial intelligence is transforming medical imaging How artificial intelligence is transforming medical imaging. A decade ago, deep learning prototypes wowed conferences but rarely touched patients. By June 2025, 777 artificial intelligence-enabled dev IntuitionLabs·https://intuitionlabs.ai**AI** in Radiology : Why Human Radiologists Are Still Essential Medical imaging has been a cornerstone of modern diagnosis since Röntgen's discovery of X‐rays in 1895. Radiology – the medical specialty using X‐rays, CT, MRI, ultrasound, PET and other modalities – Facebook·https://www.facebook.com**Radiology** now makes up 76% of every AI device the FDA has ever ...Radiology now makes up 76% of every AI device the FDA has ever cleared. But new research shows a catch: when AI is wrong, radiologists' accuracy can drop... Imaging Technology News·https://www.itnonline.com CMS Reimburse AI Triage Solution Diagnostic Foundation Model This follows a recent recognition from the FDA, who granted CARE Body CT Multi-Triage with Breakthrough Device Designation in September 2025 and FDA clearance in January 2026. Abdominal CT imaging rep

Several medical AI vendors offer FDA-cleared computer-assisted triage and notification software specifically designed to handle X-ray volumes (particularly chest and musculoskeletal plain films).

Key companies providing FDA-cleared X-ray triage and detection solutions include:

• Qure.ai offers the qXR-Detect tool, which holds FDA clearances for chest X-ray triage and detection—including critical findings like pneumothorax, pleural effusion, and lung nodule identification.
• AZmed provides the AZchest and AZtrauma modules within its Rayvolve AI suite, which have received FDA 510(k) clearances to assist in triaging chest X-rays for thoracic abnormalities (pneumothorax/pleural effusion) and identifying acute musculoskeletal bone fractures.
• Lunit offers Lunit INSIGHT CXR Triage , an FDA-cleared solution that automatically analyzes chest X-rays and prioritizes emergent cases like pleural effusion and pneumothorax for the worklist.
• Bering Limited develops BraveCX , an FDA 510(k)-cleared radiological triage and notification software built to spot urgent conditions such as pneumothorax and pleural effusion on adult chest X-rays.
• Aidoc while historically known for comprehensive CT workflow triage, has expanded its enterprise aiOS platform and secured FDA Breakthrough Device Designation for X-ray-focused assistive text and reporting tools.

If you'd like to narrow this down, please let me know:

• Are you primarily looking to triage chest X-rays, musculoskeletal/trauma X-rays , or both?
• What PACS/RIS vendor or enterprise viewer does your radiology department currently use?

Several vendors offer FDA-cleared AI triage and prioritization software for medical imaging, including chest X-rays. These systems are generally designed to flag or prioritize urgent cases for radiologist review, not replace radiologists. The FDA maintains an AI-enabled medical device list that includes cleared/authorized AI imaging products.

Some notable vendors and products:

For a department specifically overwhelmed by high X-ray volume, the evaluation criteria usually include:

• Modality coverage: chest X-ray vs. CT vs. mixed radiology.
• Findings supported: pneumothorax, pleural effusion, pneumonia, fractures, hemorrhage, etc.
• Workflow integration: PACS/RIS integration, DICOM routing, worklist prioritization, and alerting.
• False-positive burden: whether the AI reduces turnaround time without creating alert fatigue.
• Deployment model: cloud vs. on-premises, cybersecurity review, and data governance.
• Regulatory scope: verify the exact FDA clearance for the intended indication, since a vendor may have multiple products with different cleared uses.

If your main pain point is backlog of chest X-rays, I would start by comparing chest-X-ray triage products (for example Qure.ai, Lunit, AZmed, Annalise.ai, and similar vendors) against your current PACS workflow and turnaround-time metrics.

Yes. If your bottleneck is plain-film X-rays, especially chest X-rays, there are several vendors with FDA-cleared AI products designed specifically to prioritize/triage studies for radiologist review.

The FDA classifies this category as “radiological computer-assisted triage and notification software” (QAS/QFM)—software intended to identify or prioritize time-sensitive imaging for review, rather than replace the radiologist's interpretation.

Who I'd put on your shortlist

For a health system dealing with high overall X-ray volume, rather than a single finding such as pneumothorax, I'd start with Annalise.ai, Aidoc, Lunit, and VUNO. Their products are more relevant to broad chest-X-ray workflow than the narrower pneumothorax-only offerings.

One important distinction: “FDA-cleared” doesn't mean the AI autonomously diagnoses the patient. These products are generally cleared to detect specified findings and/or prioritize the worklist, with the radiologist remaining responsible for interpretation.

If you tell me what X-rays you are dealing with (chest, MSK, ED trauma, inpatient, etc.) and your PACS/RIS, I can narrow this to the 3–5 strongest vendors and compare FDA indications, findings covered, integration, published performance, and likely workflow impact.

Several prominent medical imaging AI vendors offer FDA-cleared software specifically designed to triage and prioritize X-rays (particularly chest and trauma radiographs) on the radiologist's worklist.

• AZmed : Offers AZchest and AZtrauma , which hold FDA 510(k) clearances to triage critical findings like pneumothorax, pleural effusion, lung nodules, and acute musculoskeletal fractures.
• Qure.ai : Features the qXR product suite (including qXR-Detect), which possesses broad FDA clearances covering critical chest X-ray findings like pneumothorax, pleural effusion, and lung nodule identification to assist emergency and radiology worklists.
• Lunit : Provides Lunit INSIGHT CXR Triage , an FDA-cleared computer-assisted triage and notification software built to instantly flag emergency chest X-ray cases such as pneumothorax and pleural effusions.
• Annalise.ai : Offers Annalise Triage CXR , which has earned multiple FDA clearances for time-sensitive chest X-ray findings like tension pneumothorax, pleural effusion, and pneumoperitoneum.
• Bering Ltd : Markets BraveCX , an FDA-cleared AI triage and notification tool optimized for adult chest X-rays to prioritize urgent conditions like pneumothorax and pleural effusion.
• VUNO : Features VUNO Med-Chest X-ray Triage , which has received FDA 510(k) clearance to rapidly screen and classify chest radiographs for urgent abnormalities.

Would you like to narrow this down by specific modalities (e.g., chest X-rays vs. musculoskeletal) or discuss PACS/EMR integration requirements for your department?