FDA-cleared profile
Spectronic Medical AB
Authorized purpose: MRI Planner creates synthetic CT images for photon external-beam radiation planning from MRI and can generate healthy-structure contours for specified brain, head-and-neck, and pelvic workflows; it is not intended to contour tumors or clinical target volumes.
Product overview
Authorized purpose: MRI Planner creates synthetic CT images for photon external-beam radiation planning from MRI and can generate healthy-structure contours for specified brain, head-and-neck, and pelvic workflows; it is not intended to contour tumors or clinical target volumes.
Overview status: Source-reviewed overview
Clinical role: MRI Planner creates synthetic CT images for photon external-beam radiation planning from MRI and can generate healthy-structure contours for specified brain, head-and-neck, and pelvic workflows; it is not intended to contour tumors or clinical target volumes.
Evidence from the reviewed source record: K211841 reports 244 MR/CT patients for synthetic CT development and 175 MR patients for prostate contours. Dose testing included 58 pelvic and 75 brain or head-and-neck patients, with average dose differences near zero and high-dose gamma averages of 99.8% to 99.9%; auto-contour Dice values were 0.95 for bladder, 0.90 for colon, and 0.96 for femoral heads in 51 patients.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact indications name these trained users and do not name radiation therapists.
The exact device description supports a DICOM MR image-stack input; patient metadata and release-specific planning inputs are not stated.
The exact device description supports synthetic CT and contour outputs and describes contours as a starting point for manual delineation; it does not state approval or session-management wording.
The exact packet provides the tumor/CTV and display/storage boundaries and the instruction to use existing radiotherapy-planning software; qualified final approval wording is not stated.
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.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact indications establish brain, head-neck, pelvis, and the prostate-patient bladder, colon, and femoral-head contour scope; the current brain-only anatomy is too narrow. Controlled directory display reconciled from exact FDA wording: MRI Planner is indicated for radiotherapy planning of adult patients for primary and metastatic cancers in the brain and head-neck regions, as well as soft tissue cancers in the pelvic region. MRI Planner generates synthetic CT images for radiation attenuation estimation purposes for the pelvis, brain and head-neck regions only. MRI Planner generates automatically derived contours of the bladder, colon and femoral heads, for prostate cancer patients only. -> Brain.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Current vendor materials are product-family evidence for K211841; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Current vendor materials are product-family evidence for K211841; confirm the exact cleared version, enabled options, deployment, and local compatibility.
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.
Current vendor materials are product-family evidence for K211841; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K211841 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
DICOM MRI, synthetic CT, RTSTRUCT, and planning-system exchange; validate registration, patient identity, geometry, density assignment, dose, and export.
product family · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.
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. Synthetic CT and auto-contours are limited to labeled anatomy and structures and are not tumor or clinical-target-volume delineation; qualified staff must verify images, contours, dose, and plans before treatment.
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 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
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. Track these product-specific limits: Synthetic CT and auto-contours are limited to labeled anatomy and structures and are not tumor or clinical-target-volume delineation; qualified staff must verify images, contours, dose, and plans before treatment.
product family · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.
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 endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
244 patients
58 patients
75 patients
0.02 %
99.9 %
0.95 coefficient
0.9 coefficient
0.96 coefficient
K211841
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
3 unlinked candidate evidence records are retained for source review and excluded from this evidence display.
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, 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.
The refreshed discovery snapshot contains 6 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 6 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, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, evidenceSummary, anatomy, intendedUsers, input, output, limitations, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: reimbursement, radiationTherapyPaymentContext
Scope: productFamilyContext, workflowRole, implementationCapabilities
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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