FDA-cleared profile
Brainlab AG
Brainlab Elements Image Fusion, Image Fusion Angio, Fibertracking, Contouring, and BOLD MRI Mapping support co-registration, white-matter visualization, structure outlining, and functional-activation visualization for cranial or extracranial surgery and preplanning of cranial or extracranial radiotherapy.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
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.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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.
The exact FDA decision and checked recall snapshot do not establish a complete local postmarket monitoring protocol. Track version, population, anatomy, protocol, input quality, edits, failures, repeats, downstream effects, downtime, incidents, recalls, and updates locally.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K243633 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
Exact public integration details remain incomplete; establish and test the supported input, output, identity, routing, archive, report, and downtime contract locally.
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 exact labeled population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Generated or modified contours and plans require qualified review, editing when needed, independent checks, and final approval before treatment.
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 reviewed public material; productivity or value claims require local evidence.
Monitor by exact hardware, software, model, and 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. No exact native-submission recall record was found in the checked snapshot; this does not exclude other product-family or later signals.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
No exact submission-linked sensitivity endpoint with a verified population, threshold, tested version, and source was promoted.
No exact submission-linked specificity endpoint with a verified population, threshold, tested version, and source was promoted.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA 510(k) decision evidence package reviewed for exact submission identity and labeled scope · Labeled population and configuration described in the K243633 FDA decision material
exact submission · Tested version: Brainlab Elements configuration described in K243633 · Sponsor or vendor studyK243633
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating license or hardware 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 StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
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.
Twenty PubMed records and five trial records were screened. Some concern Brainlab Elements product-family workflows, but none identifies the exact 7.0/5.0 software configurations and K243633 linkage. No evidence was promoted, and all 25 candidates remain quarantined. The current discovery snapshot contains 20 PubMed and 5 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, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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