Authorized purpose: BoneView 1.1-US analyzes eligible 2D radiographs as a concurrent fracture-reading aid. Limb examinations apply to patients aged 2 years and older; pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine are limited to adults older than 21 years. Clinical users retain diagnostic and patient-management responsibility.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: BoneView 1.1-US analyzes eligible 2D radiographs as a concurrent fracture-reading aid. Limb examinations apply to patients aged 2 years and older; pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine are limited to adults older than 21 years. Clinical users retain diagnostic and patient-management responsibility.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: BoneView 1.1-US analyzes eligible 2D radiographs as a concurrent fracture-reading aid. Limb examinations apply to patients aged 2 years and older; pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine are limited to adults older than 21 years. Clinical users retain diagnostic and patient-management responsibility.
Which images or clinical context are in scope?Modality: X-ray/Radiography Anatomy or clinical context: Spine Input: DICOM 2D radiographs in specified views for ankle, foot, knee, tibia/fibula, wrist, hand, elbow, forearm, humerus, shoulder, clavicle, pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine, subject to age-specific labeling.
Who uses it?Intended users: Clinicians authorized to diagnose fractures in primary care, emergency medicine, urgent care, specialty care such as orthopedics, and radiologists reviewing radiographs.
What does the software produce?Output: A configurable summary image and processed result images with solid or dotted fracture bounding boxes, processing frames, finding counts, and out-of-indication cautions; results can be toggled while original images remain unchanged.
What is its most important limitation?Key limitation: Not indicated below age 2. Pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine are adult-only. Use is limited to the specified body parts and views; out-of-scope images can return NOT AVAILABLE. Results are concurrent decision support and do not replace clinical interpretation.
Clinical takeaway
Clinical role: BoneView 1.1-US analyzes eligible 2D radiographs as a concurrent fracture-reading aid. Limb examinations apply to patients aged 2 years and older; pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine are limited to adults older than 21 years. Clinical users retain diagnostic and patient-management responsibility.
Evidence takeaway
Evidence from the reviewed source record: The exact submission adds pediatric indications using a 2,000-radiograph standalone study and references the unchanged algorithm's earlier 24-reader, 480-case adult MRMC study. Pediatric operating points and adult aided-reader endpoints are kept distinct.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
BoneView 1.1-US analyzes eligible 2D radiographs as a concurrent fracture-reading aid. Limb examinations apply to patients aged 2 years and older; pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine are limited to adults older than 21 years. Clinical users retain diagnostic and patient-management responsibility.
Clinicians authorized to diagnose fractures in primary care, emergency medicine, urgent care, specialty care such as orthopedics, and radiologists reviewing radiographs.
Concurrent detection and localization aid during radiograph interpretation; the clinical user makes the primary diagnosis and patient-management decision.
A configurable summary image and processed result images with solid or dotted fracture bounding boxes, processing frames, finding counts, and out-of-indication cautions; results can be toggled while original images remain unchanged.
Not indicated below age 2. Pelvis, hip, femur, ribs, thoracic spine, and lumbosacral spine are adult-only. Use is limited to the specified body parts and views; out-of-scope images can return NOT AVAILABLE. Results are concurrent decision support and do not replace clinical interpretation.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
BoneView receives studies from a DICOM source through an intermediate DICOM node and returns result files to a DICOM destination such as PACS or radiological equipment for viewing or onward transfer. Source and destination can differ.
The exact FDA comparison table labels the device HIPAA compliant; it does not disclose the control scope, audit period, encryption, access-control, vulnerability-management, or incident-response evidence needed for procurement review.
Exact-version onboarding, role-based training, competency checks, support response, and retraining after updates were not established.
Monitoring and change control
Monitor age and body-part eligibility, supported-view routing, NOT AVAILABLE results, bounding-box operating point, DICOM delivery, disagreements and overrides, false negatives and false positives, downstream imaging/referrals, downtime, updates, complaints, and exact-submission recalls.
FDA source
Exact FDA submission
Checked 2026-09-08
Buyer acceptance guidance derived from FDA labeling and NICE evidence gaps; it is not a claimed vendor monitoring service.
The exact packet describes automatic receipt through an intermediate DICOM node and return of summary/result images to a potentially different DICOM destination for PACS or equipment viewing.
Gleamer's current US BoneView page describes automatic second reading of trauma X-rays integrated into the reading workflow for adults and children over age 2. Current family claims are not used to broaden the exact K222176 body-part, view, or age labeling.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Evidence summary
The exact submission adds pediatric indications using a 2,000-radiograph standalone study and references the unchanged algorithm's earlier 24-reader, 480-case adult MRMC study. Pediatric operating points and adult aided-reader endpoints are kept distinct.
Pediatric standalone: 90.9% at the high-sensitivity operating point and 79.2% at the high-specificity operating point; adult carried-forward MRMC aided sensitivity: 75.2%.
Pediatric standalone: 82.1% at the high-sensitivity operating point and 96.5% at the high-specificity operating point; adult carried-forward MRMC aided specificity: 95.6%.
DesignStandalone fracture-detection performance comparison between pediatric and adult datasets at prespecified high-sensitivity and high-specificity operating points.
Population2,000 radiographs from patients aged 2-21 years, balanced between fracture-positive and fracture-negative examinations and spanning the pediatric-labeled anatomy and eight manufacturers.
Scopeexact submission
Tested versionBoneView 1.1-US configuration described in K222176
Samplen=2000
IndependenceSponsor or vendor study
K222176
The packet states the pediatric dataset was separate from training, tuning, and operating-point data. Dataset separation does not establish independent investigators.
BoneView adult MRMC study carried forward in K222176
DesignFully crossed retrospective multiple-reader, multiple-case study with aided and unaided sessions separated by at least one month.
Population480 adult cases interpreted by 24 clinical readers, with a three-US-board-certified-radiologist reference standard and multiple manufacturers.
Scopeexact submission
Tested versionUnchanged BoneView algorithm carried forward in K222176 from K212365
Samplen=480
IndependenceSponsor or vendor study
K222176 · K212365
The K222176 summary says no new clinical study was conducted and carries this predicate study forward because the algorithm was unchanged.
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 2026-09-08
NICE's GBP 1-per-scan figure is an exploratory model assumption, not a BoneView quote or public list price.
Reimbursement and coding
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-08
NICE HTG739 is conditional English NHS adoption guidance, not a payer coverage or product-specific reimbursement determination.
No product-specific code
NICE HTG739 conditionally recommends BoneView for NHS use during a two-year evidence-generation period, subject to evidence-generation agreements and appropriate regulatory and DTAC approval; this is not a reimbursement determination.
NICE guidance for the NHS in England · England · Effective 2025-01-14
NICE's exploratory model uses GBP 1 per scan and states actual software, implementation, and postmarket costs are uncertain. Treat that figure as a health-technology-model assumption, not a vendor quote.
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
The exact-submission FDA recall query returned no native recall record for K222176. This limited query does not establish absence of recalls or other safety information.
Verify training: Exact-version onboarding, role-based training, competency checks, support response, and retraining after updates were not established.
Verify pricing and total cost: NICE's GBP 1-per-scan figure is an exploratory model assumption, not a BoneView quote or public list price.
Verify reimbursement and coding relevance: NICE HTG739 is conditional English NHS adoption guidance, not a payer coverage or product-specific reimbursement determination.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-08Last searched
26Fields reviewed
12Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads
Stored PubMed and trial candidates were screened by identifier and metadata only. None was promoted without full-text or registry-record review; this is not a systematic evidence review. The current discovery snapshot contains 20 PubMed and 6 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, health technology guidance, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history10 sources - 3 history items
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