FDA-cleared profile
Oncospace, Inc.
Oncospace supports protocol configuration, machine-learning dose prediction, treatment-plan objective exchange, and plan review for qualified radiation-therapy professionals. This release updated prostate and head-and-neck models and added thoracic, abdominal, and gynecological regions while keeping algorithms locked before clinical use.
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.
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.
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.
Photon-beam plans used across model development and validation in Two-institution multi-region cohort.
Tested version: Oncospace Predictive Planning product familyInstitutions contributing retrospective plans in Multi-region photon treatment plans.
Tested version: Oncospace Predictive Planning product familyManufacturer retrospective model development, internal or external performance testing, and clinical plan-quality validation · Release-specific retrospective radiation plans and supported disease-site models described in the FDA summary
exact submission · Tested version: Oncospace release cleared in K242748 · Sponsor or vendor studyK242748
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.
Retrospective development, internal testing, and clinical validation of protocol-agnostic dose-volume prediction models · 5,334 photon-beam plans across head and neck, thoracic, abdominal, and pelvic regions
product family · Tested version: Oncospace Predictive Planning product family; exact release mapping was not established for every submission · n=5334 · 2 sites · Sponsor or vendor studyPMID 42382856
Authors were affiliated with Oncospace and the publication reports company and grant support; treat it as vendor-involved product-family evidence.
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 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.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials, current product-family materials, directly relevant clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, final security architecture, contracted services, enabled modules or models, interoperability, and local acceptance remain organization-specific evidence. Automated exact-name discovery found 4 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads remain unpublished until a human confirms the exact product and tested version.
Source classes: fda ai list, fda decision summary, vendor product page, peer reviewed publication, health technology guidance, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-03.
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