Radiology AI Directory

FDA-cleared profile

brAIn™ Shoulder Positioning

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brAIn Shoulder Positioning assists preoperative planning and visualization for primary total shoulder replacement by segmenting and measuring shoulder CT anatomy and supporting manual implant planning.

Quantification and segmentation
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
brAIn Shoulder Positioning assists preoperative planning and visualization for primary total shoulder replacement by segmenting and measuring shoulder CT anatomy and supporting manual implant planning.
FDA source Exact FDA submission Checked 2026-09-04
Intended users
Shoulder surgeons and other qualified healthcare professionals.
FDA source Exact FDA submission Checked 2026-09-04
Care setting and population
Hospitals and clinics performing preoperative primary total shoulder replacement planning.
FDA source Exact FDA submission Checked 2026-09-04
Workflow role
Patient-specific shoulder segmentation, measurement, and interactive implant-planning support.
FDA source Exact FDA submission Checked 2026-09-04
Required input
Patient shoulder CT DICOM images and patient information uploaded to the application.
FDA source Exact FDA submission Checked 2026-09-04
Output and human action
Scapula and humerus segmentations, pre- and post-plan measurements, implant planning views, distalization and lateralization values, and planning screenshots or summaries.
FDA source Exact FDA submission Checked 2026-09-04
Limitations
The FDA labeling describes an information tool for planning and visualization, not autonomous surgical planning. Surgeons must review and manually plan anatomic or reverse total shoulder replacement.
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
K252665
FDA source Exact FDA submission Checked 2026-08-31
Modality
CT/CTA
FDA source Exact FDA submission Checked 2026-09-04
Anatomy
Shoulder, scapula, and humerus
FDA source Exact FDA submission Checked 2026-09-04
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2025-10-20
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 upload of CT DICOM data and patient information to a cloud-based web application with a three-dimensional interactive planning viewer.
FDA source Exact FDA submission Checked 2026-09-04
Deployment and data flow
The FDA package describes a cloud-based web application; current hosting responsibility, security, availability, retention, and site 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 shoulder surgeons and other qualified healthcare 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 K252665.
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 K252665.

exact submission · checked 2026-09-04
Source

Deployment boundary

The FDA package describes a cloud-based web application; current hosting responsibility, security, availability, retention, and site configuration remain unknown.

exact submission · checked 2026-09-04
Source

Interoperability acceptance

The FDA package describes upload of CT DICOM data and patient information to a cloud-based web application with a three-dimensional interactive planning viewer.

exact submission · checked 2026-09-04
Source

Clinical acceptance

Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K252665.

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.

Evidence summary
K252665 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for brAIn Shoulder Positioning. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
FDA source Exact FDA submission Checked 2026-09-04
Reported sensitivity
Not applicable
Not applicable Not applicable Checked 2026-09-04

Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.

Reported specificity
Not applicable
Not applicable Not applicable Checked 2026-09-04

Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K252665 FDA evidence package for brAIn™ Shoulder Positioning

FDA 510(k) decision evidence and product verification for the exact submission. · Shoulder, scapula, and humerus

exact submission · Tested version: brAIn Shoulder Positioning · Sponsor or vendor study

K252665

FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.

Source

Economics and lifecycle

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 K252665 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
10Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads

The snapshot contained no PubMed or ClinicalTrials.gov candidates; no evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-04.

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