Radiology AI Directory

FDA-cleared profile

BoneView

Gleamer

Concurrent-reading software that highlights suspected fractures on labeled adult radiographs for physician review.

MSK and bone
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

Concurrent-reading software that highlights suspected fractures on labeled adult radiographs for physician review.

Overview status: Source-reviewed overview

Clinical takeaway

BoneView adds concurrent fracture highlights within its labeled adult radiograph scope; clinicians still perform the complete image review and clinical assessment.

Evidence takeaway

The FDA submission reports standalone fracture-detection results from 8,918 adult radiographs at two operating points. Those results are limited to the stated endpoint, population, operating point, and BoneView version; they are not reader-aided or site-performance claims.

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 is a concurrent reading aid that analyzes radiographs and highlights areas suspicious for fractures in adults during physician interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Radiologists, physicians, and trained radiology or orthopedic professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Radiology and orthopedic imaging workflows in hospitals, clinics, and imaging sites.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Concurrent fracture-detection support during radiograph interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
DICOM radiographs of the labeled adult extremity, pelvic, rib, and spine regions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Result DICOM images and summary information with annotations or highlighted areas; original images are not altered.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The FDA labeling limits the supported adult radiograph views and requires physician interpretation. Results are an aid and do not replace full image review, clinical examination, or judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

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
K212365
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Ankle, foot, knee, tibia/fibula, femur, wrist, hand, elbow, forearm, humerus, shoulder, clavicle, pelvis, hip, ribs, thoracic spine, and lumbosacral spine
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-03-01
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The FDA package describes DICOM source and destination through PACS or an X-ray system, with an intermediate DICOM node, gateway, or API for processing and result return.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
The FDA package describes on-premises or cloud deployment options; current hosting, security, availability, and local configuration remain unknown.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact submission do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Use by radiologists, physicians, and trained radiology or orthopedic professionals. Follow the exact labeling, local training, supervision, and escalation requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K212365.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Release and scope verification

Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K212365.

exact submission · checked 2026-09-04
Source

Deployment boundary

The FDA package describes on-premises or cloud deployment options; current hosting, security, availability, and local configuration remain unknown.

exact submission · checked 2026-09-04
Source

Interoperability acceptance

The FDA package describes DICOM source and destination through PACS or an X-ray system, with an intermediate DICOM node, gateway, or API for processing and result return.

exact submission · checked 2026-09-04
Source

Clinical acceptance

Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K212365.

exact submission · checked 2026-09-04
Source

Economic evaluation

Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.

product family · checked 2026-09-04
Source

Lifecycle monitoring

Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.

exact submission · checked 2026-09-04
SourceSource

Evidence

Performance evidence

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
K212365 FDA decision material reports the exact evidence metrics included below for BoneView; values are limited to the stated endpoint, population, and operating point.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Value withdrawn pending re-verification
  • Corrected record
  • Exact FDA submission
  • Checked 2026-09-14

Previous value withdrawn: The legacy value combines multiple unlabeled numbers and does not identify an endpoint, operating point, population, or tested version. Use the scoped exact-submission evidence metrics instead.

Reported specificity
Value withdrawn pending re-verification
  • Corrected record
  • Exact FDA submission
  • Checked 2026-09-14

Previous value withdrawn: The legacy value combines multiple unlabeled numbers and does not identify an endpoint, operating point, population, or tested version. Use the scoped exact-submission evidence metrics instead.

Standalone sensitivity at high-sensitivity operating point

92.8 percent

  • EndpointFracture detection sensitivity
  • PopulationGlobal adult radiograph standalone dataset
  • Tested versionBoneView
Source

Standalone specificity at high-sensitivity operating point

81.1 percent

  • EndpointFracture detection specificity
  • PopulationGlobal adult radiograph standalone dataset
  • Tested versionBoneView
Source

Standalone sensitivity at high-specificity operating point

84.1 percent

  • EndpointFracture detection sensitivity
  • PopulationGlobal adult radiograph standalone dataset
  • Tested versionBoneView
Source

Standalone specificity at high-specificity operating point

93.2 percent

  • EndpointFracture detection specificity
  • PopulationGlobal adult radiograph standalone dataset
  • Tested versionBoneView
Source

K212365 FDA evidence package for BoneView

  • DesignFDA 510(k) standalone performance evaluation.
  • PopulationStandalone performance data from 8,918 adult radiographs across the labeled body regions.
  • Scopeexact submission
  • Tested versionBoneView
  • Samplen=8918
  • IndependenceSponsor or vendor study

K212365

FDA-reported global operating-point results for the exact BoneView submission.

Source

Costs and setup

Budget and ongoing governance

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 2026-09-04

No public list price or commercial contract for the exact submission and version was identified.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product payer coverage or reimbursement determination was identified in reviewed public material.

No product-specific code

No exact-product reimbursement determination identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.

Source

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
No record matched K212365 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
20Screened PubMed leads
6Screened trial leads
0Unreviewed FDA recall leads

No evidence was promoted. Several records name BoneView, but none identifies the tested build tied to K212365; NCT04532580 says FDA submission but omits the submission number and software version, and other records are pediatric, family-level, or unrelated. 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 history

Source ledger

  1. FDA 510(k) decision material K212365: BoneView

    U.S. Food and Drug Administration - Published 2022-03-01 - Accessed 2026-09-04

    Scope: identity, submission_linkage, modality, anatomy, clinical_use, intended_users, care_setting, workflow_role, input, output, limitations, evidence

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. BoneView model card (K212365)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K212365 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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