OncoStudio (OS-01)
Overview
OncoStudio (OS-01) by OncoSoft. Co. is an advanced AI-based auto-contouring software specifically designed for radiation oncology. It revolutionizes clinical workflows by transforming hours of manual organ segmentation into minutes of accurate, clinically-graded precision. The software utilizes deep-learning technology to automatically detect treatment areas and prepare organ contour samples without additional user input.
OncoStudio supports an extensive structure library, including over 160 organs at risk (OARs) and 27 clinical target volumes (CTVs), making it equipped for various contouring challenges in radiation oncology. It is compatible with global standards, supporting DICOM and HL7 FHIR for seamless integration into existing radiotherapy workflows. Recent advancements include a multimodal AI model based on a large language model (LLM) like GPT, which enhances accuracy by incorporating language-based clinical information (e.g., patient stage, disease location, surgical method) in addition to image data, enabling more precise tumor contouring.
The solution is proven in practice, having been the backbone of over 10 million contours in treatments for more than 213,000 patients. OncoSoft ensures strict protection and management of all data, holding ISO/IEC 27001 & 27701 Certification for Information Security and Privacy Management Systems.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI Auto-Contouring for target and normal organs
- Transforms manual segmentation into minutes
- Clinical-grade precision and accuracy
- Fully automatic detection and contouring
- Extensive structure library (160+ OARs, 27 CTVs)
- Supports DICOM and HL7 FHIR standards
- Integration with existing radiotherapy workflows
- Patient data management and transfer capabilities
- Multimodal AI with LLM for enhanced tumor contouring accuracy
- Local server deployment with planned cloud-based option
Use Cases
- Radiation therapy planning
- Contouring of organs at risk (OARs)
- Contouring of clinical target volumes (CTVs)
- Streamlining clinical workflows in radiation oncology departments
- Enhancing team productivity in radiotherapy
- Facilitating personalized precision radiotherapy
What Physicians Need to Know
OncoStudio (OS-01) offers significant time savings and precision in radiation therapy planning through its AI-powered auto-contouring. Physicians should leverage its extensive organ library and customizable segmentation to streamline workflows and enhance treatment plan quality. The ability to quickly review and make minor manual adjustments ensures physician oversight while maximizing efficiency. Consider its proven accuracy in various anatomical sites, especially for complex cases, to support personalized precision radiotherapy. Keep an eye on the planned cloud-based version for potentially easier future deployment and access.
OncoStudio (OS-01) is designed for broad compatibility within existing oncology workflows, adhering to DICOM and HL7 FHIR standards for seamless data exchange. It integrates with commercially available hardware and software, and future developments include enhanced interfacing with external beam radiation therapy planning systems (TPS). While currently a local server-based solution, the upcoming cloud-based offering in 2026 will provide more flexible integration possibilities.
Details
| Category | Oncology AI |
| Pricing | Contact for pricing |
| Deployment | On-premise (local servers), cloud-based version planned for 2026. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated OncoStudio obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) on February 28, 2025 (K242994). It is a standalone software providing deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images for radiation oncology treatment planning. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Radiology |
What the Web Says
OncoStudio (OS-01) is a standalone software developed by OncoSoft Co., Ltd. that provides deep-learning-based automatic contouring of organs at risk from CT images for radiotherapy planning. It is intended to be used by clinicians as an initial contouring tool, which then needs to be confirmed by the radiation oncology department. The device received FDA clearance (K242994) on February 24, 2025.
Overall: MixedStrengths
- Deep-learning-based automatic contouring of organs at risk
- Aids in radiotherapy planning
- FDA-cleared (K242994)
- Can be used as an initial contouring tool for clinicians
- Patient management features
- Review of processed images and file management
Limitations
- Requires confirmation by the radiation oncology department
- Does not automatically detect or contour lesions
- No information available from G2, Capterra, Reddit, or tech reviewers
- Limited public information on physician or healthcare IT reviews currently available
Based on reviews from: Radiotherapy planning radiology AI tools | Buyer shortlist, Radiotherapy planning imaging radiology AI tools | FDA-cleared directory, Search FDA-cleared listings - Radiology AI Tools Directory, Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics, 2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics, OncoSoft. Co., Ltd. February 24, 2025 Boram Kim RA/QA Manager 37, Myeongmul-gil, Seodaemun-gu SEOUL, 03776 KOREA, SOUTH Re: K2 - accessdata.fda.gov, Radiological Image Processing Software For Radiation Therapy QKB - FDA.report
Last updated: 2026-07-18
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