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510(k) Data Aggregation
K Number
K242994Device Name
OncoStudio (OS-01)
Manufacturer
OncoSoft. Co., Ltd.
Date Cleared
2025-02-24
(151 days)
Product Code
QKB
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
OncoSoft. Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OncoStudio provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images. This software could be used as an initial contouring for the clinicians to be confirmed by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.
- Deep learning contouring from Head & Neck, Thorax, Abdomen, and Pelvis
- Generates DICOM-RT structure of contoured objects
- Manual Contouring
- Receive, transmit, store, retrieve, display, and process medical images and DICOM objects
Device Description
OncoStudio is a standalone software that provides deep-learning-based automatic contouring to organs at risk in DICOM-RT format from CT images. This software could be used as an initial contouring for the clinicians to be confirmed by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.
- Deep learning contouring from Head & Neck, Thorax, Abdomen, and Pelvis
- Generates DICOM-RT structure of contoured objects
- Manual Contouring
- Receive, transmit, store, retrieve, display, and process medical images and DICOM objects
It also has the following general functions:
- Patient management;
- Review of processed images;
- Open and Save of files.
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