ARTAssistant
FDA 510(k) K250780 · Manteia Technologies Co., Ltd.
510(k) numberK250780
Submission
- Device name
- ARTAssistant
- Applicant
- Manteia Technologies Co., Ltd.
Xiamen, CN - Received
- March 14, 2025
- Decision date
- December 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKB – Radiological Image Processing Software For Radiation Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image…
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More from Taiwan Medical Imaging Co., Ltd.
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| K260733 | MRIA Radiation Therapy Information System (MRIA)IYE · Traditional | 08/26/2026SE |
| K251351 | AccuContour 4.0QKB · Traditional | 01/23/2026SE |
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| K223834 | AccuCheckIYE · Traditional | 07/20/2023SE |
| K223724 | Mozi TPSMUJ · Traditional | 07/10/2023SE |
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Questions and answers
When was ARTAssistant cleared by the FDA?
ARTAssistant (K250780) received a 510(k) decision of Substantially Equivalent on December 5, 2025, 266 days after the submission was received.
What is the product code of K250780?
The FDA product code is QKB – Radiological Image Processing Software For Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.2050.