FDA-cleared profile
Elekta Solutions AB
The EMLA family delivers external-beam radiation therapy for adult and pediatric patients with benign, malignant, or metastatic disease. Authorized techniques vary by model: Synergy and Harmony include conventional and fractionated delivery; Infinity and Harmony Pro add SBRT/SABR; Versa HD and Evo also support SRS and specified functional disorders.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Added in P2 round17 from the exact FDA decision material; later product-family claims remain separate.
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.
Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K252188 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Treatment-management, record-and-verify, imaging, planning, and accessory interfaces are configuration dependent and require end-to-end commissioning.
exact submission · checked 2026-09-03Test 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. Do not transfer technique claims across models. Confirm the exact accelerator, energy, imaging, motion-management, SRS/SBRT, pediatric, and functional-disorder configuration in the installed labeling and acceptance package.
exact submission · checked 2026-09-03Define 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 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model 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. Track the limits that matter for this product: Do not transfer technique claims across models. Confirm the exact accelerator, energy, imaging, motion-management, SRS/SBRT, pediatric, and functional-disorder configuration in the installed labeling and acceptance package.
exact submission · checked 2026-09-03Revalidate 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. Candidate literature without exact product and version linkage is not shown as product evidence.
Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.
Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K252188
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Costs and setup
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 hardware or license basis, enabled features, 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.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Twenty PubMed records and ten trial records were screened. The records concern EMLA anesthetic cream or unrelated topics, not the Elekta EMLA systems and exact K252188 configurations. No evidence was promoted, and all 30 candidates remain quarantined. 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, vendor product page, reimbursement policy, fda device recall, fda decision material, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: reimbursement, radiationTherapyPaymentContext
Scope: productFamily, workflowRole, training, implementationCapabilities, currentCommercialContext
Regulatory record
510(k)
Research record
human reviewed
Alternatives
RaySearch Laboratories AB (PUBL)
RayStation and RayPlan releases covered by K240398 are configurable radiotherapy and medical-oncology software that proposes or supports treatment plans from user inputs, with...
OncoSoft. Co., Ltd.
OncoStudio OS-01 creates initial deep-learning organs-at-risk contours from CT images of the head and neck, thorax, abdomen, and pelvis for radiation-oncology review, editing, and...
Wisdom Technologies., Inc.
DeepContour uses deep-learning CT processing to generate editable organ contours and RTSTRUCT objects for selected adult radiation-treatment planning workflows, with quantitative...
Siemens Medical Solutions USA, Inc.
syngo.via RT Image Suite VB80 supports trained radiation-oncology professionals with multimodality visualization, registration, advanced contouring, treatment preparation,...