FDA-cleared profile
Brainlab AG
Brainlab Elements are software applications for processing medical-image data to support image-guided surgery and radiation-treatment planning; the exact submission includes contouring, rigid and deformable image fusion, DTI fiber tracking, task-based BOLD MRI mapping, and cerebrovascular image co-registration.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Prior source-backed dossier value: Trained healthcare professionals, physicians, technicians, surgeons, or other users specified by the exact submission.
Prior source-backed dossier value: Medical-image viewing, processing, segmentation, measurement, registration, communication, or planning support within the exact labeled scope.
Prior source-backed dossier value: DICOM or other medical-image data from the exact labeled modalities, scanners, and user workflow.
Prior source-backed dossier value: Images, measurements, segmentations, models, reports, or planning information for professional review.
Prior source-backed dossier value: Supported modalities, modules, anatomy, patient population, and output use are submission-specific; source images and generated results require expert review.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.
Exact deployment topology, hosting, network boundaries, PHI flow, retention, update mechanism, and local operational requirements are not established for this submission. The exact public FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response. Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.
Medical-image viewing, processing, segmentation, measurement, registration, communication, or planning support within the exact labeled scope.
exact submission · checked 2026-09-04Submission-anchored workflow summary, not a local acceptance or deployment result.
DICOM or other medical-image data from the exact labeled modalities, scanners, and user workflow.
exact submission · checked 2026-09-04Exact supported inputs and protocol limits must be confirmed from the complete labeling.
Images, measurements, segmentations, models, reports, or planning information for professional review.
exact submission · checked 2026-09-04Output review, editing, approval, export, and downstream use remain release- and site-specific.
Exact deployment topology and operational boundaries remain unestablished.
exact submission · checked 2026-09-04Confirm hosting, PHI flow, retention, access, updates, downtime, and support obligations before procurement or clinical use.
The exact FDA material describes processing of medical-image data and DICOM-supported modules; local image import, export, treatment-planning connection, identity, and display require confirmation.
exact submission · checked 2026-09-04Validate the local workflow against the exact release and enabled options.
Current vendor material is product-family context for K223106 only; exact release, enabled options, deployment, security, interoperability, pricing, and local workflow require confirmation.
product family · checked 2026-09-04Vendor material is not exact-release evidence unless that linkage is separately proven.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K223106 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA material describes DICOM transfer to and from PACS or storage, image viewing and processing, co-registration, segmentation, and 3D DICOM output.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The exact supported applications, modalities, anatomy, protocols, options, and review path are submission-specific; outputs require professional review and do not establish a general product-wide sensitivity or specificity.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor K223106 by exact hardware, software, model, algorithm version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Prior source-backed dossier value: The exact FDA decision material for K223106 supports the submission-specific intended use and regulatory verification summarized here; it does not establish a general product-wide sensitivity or specificity value.
No exact-submission and version-linked sensitivity endpoint is promoted; candidate or product-family values were not substituted. Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
No exact-submission and version-linked specificity endpoint is promoted; candidate or product-family values were not substituted. Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA 510(k) regulatory decision material and submission-specific verification or validation evidence for K223106; this is regulatory evidence, not an independent clinical effectiveness study. · The labeled population, anatomy, images, and test materials described in the exact FDA decision material for K223106; a broader clinical population is not established here.
exact submission · Tested version: Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) (K223106) · Sponsor or vendor studyK223106
The exact FDA material is submission-specific and should not be generalized to other versions, enabled options, sites, protocols, or clinical outcomes.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review. No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Screened 20 PubMed and 10 ClinicalTrials.gov records. The records are generic image-fusion or unrelated clinical studies and do not identify the exact Brainlab Elements applications, tested versions, or K223106; all 30 were quarantined and none was promoted. The current discovery snapshot contains 20 PubMed and 10 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, vendor product page, implementation documentation, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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