FDA-cleared profile
Oncospace, Inc.
Authorized purpose: Oncospace supports trained radiation therapy professionals with protocol configuration, machine-learning achievable-dose prediction, planning-objective exchange, and plan review across head-and-neck, thoracic, abdominal, and pelvic workflows using locked models.
Product overview
Authorized purpose: Oncospace supports trained radiation therapy professionals with protocol configuration, machine-learning achievable-dose prediction, planning-objective exchange, and plan review across head-and-neck, thoracic, abdominal, and pelvic workflows using locked models.
Overview status: Source-reviewed overview
Clinical role: Oncospace supports trained radiation therapy professionals with protocol configuration, machine-learning achievable-dose prediction, planning-objective exchange, and plan review across head-and-neck, thoracic, abdominal, and pelvic workflows using locked models.
Evidence from the reviewed source record: Exact FDA summaries describe retrospective model development, internal and external testing, and clinical validation intended to preserve plan quality while reducing planning effort. A 2026 vendor-authored publication reports a larger two-institution development and validation program; its financial-support disclosure and release mapping should be considered before generalizing results.
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.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact indication describes protocol setup, plan association, dose-prescription and dosimetric-goal submission, and plan review; it does not establish the dossier's protocol-scorecard wording.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
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.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Request the current security package and contract controls for the proposed deployment.
This release updated prostate and head-and-neck models and added thoracic, abdominal, and gynecological regions while keeping algorithms locked before clinical use. Procurement should map the installed build, modules, models, anatomies, inputs, and outputs to K242748 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that an earlier cleared release includes them.
DICOM-RT compliant browser-based workflow with treatment-planning-system scripts used to transmit DICOM files and plan parameters; exact supported TPS versions and scripting permissions require local verification.
exact submission · checked 2026-09-03Test representative imports, exports, identifiers, orientation, geometry, structure names, units, failure handling, and round trips in the local environment.
Use a signed local test set spanning supported anatomies, scanners, protocols, unusual or postsurgical anatomy, and small or complex structures. Measure edit burden, rejection, downstream plan effects, and reviewer agreement rather than relying only on average overlap metrics.
product family · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model total annual and per-plan cost against hands-on and elapsed time after review, correction, failed transfers, rework, support, upgrades, downtime, and any effect on plan quality or throughput.
product family · checked 2026-09-03Vendor time-saving results are scenario inputs, not guaranteed local savings.
Monitor prediction and plan-review performance by software and model version, disease site, protocol, target and OAR geometry, structure-name mapping, objective acceptance, optimization iterations, plan quality, overrides, transfer failures, and update. Revalidate when models, protocols, TPS versions, interfaces, or clinical policies change.
product family · checked 2026-09-03Trend failures and edits by exact software version, model, anatomy, scanner, protocol, and site.
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 an applicable primary endpoint for this radiation-planning software. Review structure-, model-, workflow-, and release-specific geometric, clinical-review, dosimetric, and edit-burden evidence instead.
Specificity is not an applicable primary endpoint for this radiation-planning software. Review structure-, model-, workflow-, and release-specific geometric, clinical-review, dosimetric, and edit-burden evidence instead.
5334 plans
2 institutions
K242748
Manufacturer evidence submitted for substantial equivalence. This release updated prostate and head-and-neck models and added thoracic, abdominal, and gynecological regions while keeping algorithms locked before clinical use.
PMID 42382856
Authors were affiliated with Oncospace and the publication reports company and grant support; treat it as vendor-involved product-family evidence.
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 release was found. Obtain a written quote separating license basis, sites or users, enabled modules or models, implementation, interfaces, compute, storage, training, support, upgrades, renewal, and exit costs.
No separate named-product payment identified in reviewed CMS 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. Maintain ongoing FDA and vendor surveillance.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 4 PubMed and 1 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 4 PubMed and 1 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, peer reviewed publication, health technology guidance, 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, anatomy, intendedUsers, input, limitations, output, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: reimbursement, radiationTherapyPaymentContext
Scope: limitations, training, pricing, evidenceSummary, economics, monitoring, implementationCapabilities
Scope: productFamily, workflowRole, integration, deployment, security, currentCommercialContext, implementationCapabilities
Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, economics, monitoring, implementationCapabilities
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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