BoneView is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs of: Ankle, Foot, Knee, Tibia/fibula, Femur, Wrist, Hand, Elbow, Forearm, Humerus, Shoulder, Clavicle, Pelvis, Hip, Ribs, Thoracic spine, and Lumbosacral spine. BoneView 1.1-US is intended for use as a concurrent reading aid during the interpretation of radiographs. BoneView 1.1-US is for prescription use only.
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
BoneView is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs of: Ankle, Foot, Knee, Tibia/fibula, Femur, Wrist, Hand, Elbow, Forearm, Humerus, Shoulder, Clavicle, Pelvis, Hip, Ribs, Thoracic spine, and Lumbosacral spine. BoneView 1.1-US is intended for use as a concurrent reading aid during the interpretation of radiographs. BoneView 1.1-US is for prescription use only.
Public source Exact FDA submission Checked 2026-09-01
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
Clinicians with the authority to diagnose fractures in various settings including primary care (e. g., family practice, internal medicine), emergency medicine, urgent care, and specialty care (e. g. orthopedics), as well radiologists who review radiograph
Public source Exact FDA submission Checked 2026-09-01
Intended-user text reported in the exact-submission ACR model card.
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
K222176
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Public source Exact FDA submission Checked 2026-08-13
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Public source Exact FDA submission Checked 2026-08-13
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
Vendor confirmation Exact FDA submission Checked 2026-08-13
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
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.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
BoneView regulatory performance study summary
Stand-alone performance and reader study (ACR AI Central category) · Adult and Pediatric
exact submission · Tested version: 1.1-US · n=10918 · Independence not established
K222176
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-08-13
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-08-31
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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.
Exact FDA record reviewedStatus
2026-09-04Last searched
19Fields reviewed
6Source classes checked
20Unreviewed PubMed leads
6Unreviewed trial leads
0Unreviewed FDA recall leads
Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Automated exact-name discovery found 20 PubMed and 6 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, acr ai central product, pubmed, clinical trials, openfda device recall
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