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Last updated: June 14, 2026
Back to directoryGleamer BoneView medical AI product profile
Radiology AI product for detecting and highlighting fractures on trauma X-rays inside clinician-reviewed reading workflows.
Medical imaging and radiology
Best fit
Teams that need fracture-detection support for high-volume trauma X-rays while preserving radiologist or clinician interpretation.
- Primary use case
- AI-assisted fracture detection and trauma X-ray second-reader workflow support
- Audience
- Radiology departments, emergency departments, orthopedic clinics, urgent care groups, and imaging networks
- Risk level
- High
- Pricing signal
- Enterprise radiology pricing; verify current country availability, module scope, and integration terms.
- Official sources
- 4 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared Class II radiological computer-assisted detection/diagnosis software for fracture under BoneView 1.1-US. |
|---|---|
| Review route | 510(k) K222176, with K212365 listed as the predicate BoneView clearance. |
| Intended use | Analyzes trauma radiographs with machine-learning techniques to identify and highlight suspected fractures during clinician review; the 510(k) summary describes prescription use as a concurrent reading aid. |
| Verification note | Confirm the deployed version, country-specific label, adult and pediatric age limits, covered anatomy, compatible views, warnings, PACS workflow, and clinician final-interpretation responsibilities before use. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf22 |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Gleamer BoneView as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify BoneView US K222176 and any local CE, Health Canada, or other authorization for the exact module, anatomy, patient age, and clinical site. |
|---|---|
| Privacy | Review imaging-data flow, DICOM metadata, pseudonymized patient data, processor/controller roles, subcontractors, security controls, and retention in the deployment contract. |
| Evidence | Validate performance on local trauma X-rays, pediatric and adult case mix, fracture type, body region, scanner workflow, false positives, false negatives, and report turnaround. |
| Workflow | Best used as a second-reader and prioritization aid inside existing radiology or emergency workflows, with explicit responsibility for accepting, rejecting, and documenting AI marks. |
Where Gleamer BoneView fits
Gleamer describes BoneView as an AI second-reader for trauma bone X-rays, with workflow integrations, worklist support, and clinical-study references; its regulatory page states that BoneView US is FDA-cleared under K222176 and explains personal-data processing for imaging users.
Not for: Autonomous fracture diagnosis, unsupported body regions or age groups, or applying non-U.S. Gleamer modules as though they share BoneView's U.S. clearance.
What to verify before using Gleamer BoneView
- FDA K222176 intended use, covered anatomy, patient age limits, warnings, and region-specific availability.
- How BoneView results appear in PACS, worklists, reports, or shadow-mode review and who accepts or rejects findings.
- Image routing, DICOM metadata handling, pseudonymization, retention, and data-controller terms for clinical imaging data.
- Local impact on missed fractures, reading time, false positives, urgent escalation, and radiologist or emergency clinician workload.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.gleamer.ai / us / copilot
- www.gleamer.ai / us / copilot
- www.gleamer.ai / privacy-policy
- www.accessdata.fda.gov / cdrh_docs / pdf22
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