AccuContour
FDA 510(k) K221706 · Manteia Technologies Co., Ltd.
510(k) numberK221706
Submission
- Device name
- AccuContour
- Applicant
- Manteia Technologies Co., Ltd.
Xiamen, CN - Received
- June 13, 2022
- Decision date
- March 9, 2023
- 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…
Other 510(k)s with product code QKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262452 | AutoContour (RADAC V6)QKB · Special | Radformation, Inc. | 08/14/2026SE |
| K261306 | AI Contouring (VA10A)QKB · Traditional | Varian Medical Systems | 07/10/2026SE |
| K260528 | OncoStudioQKB · Traditional | Oncosoft. Inc., | 07/02/2026SE |
| K252548 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Healthcare GmbH | 04/10/2026SE |
| K252190 | DeepBT Detector-PlusQKB · Traditional | Aitewan Biomedical Technology, Inc. | 04/10/2026SE |
| K253270 | Contour ProtégéAI+QKB · Traditional | Mim Software, Inc. | 03/27/2026SE |
| K260509 | AutoContour (RADAC V5)QKB · Special | Radformation, Inc. | 03/19/2026SE |
| K251306 | Seg Pro V3 (RT-300)QKB · Traditional | Ever Fortune.Ai, Co., Ltd. | 01/28/2026SE |
| K251351 | AccuContour 4.0QKB · Traditional | Manteia Technologies Co., Ltd. | 01/23/2026SE |
| K250780 | ARTAssistantQKB · Traditional | Manteia Technologies Co., Ltd. | 12/05/2025SE |
More from Manteia Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260733 | MRIA Radiation Therapy Information System (MRIA)IYE · Traditional | 08/26/2026SE |
| K251351 | AccuContour 4.0QKB · Traditional | 01/23/2026SE |
| K250780 | ARTAssistantQKB · Traditional | 12/05/2025SE |
| K250696 | AccuCheckIYE · Traditional | 10/24/2025SE |
| K223834 | AccuCheckIYE · Traditional | 07/20/2023SE |
| K223724 | Mozi TPSMUJ · Traditional | 07/10/2023SE |
Questions and answers
When was AccuContour cleared by the FDA?
AccuContour (K221706) received a 510(k) decision of Substantially Equivalent on March 9, 2023, 269 days after the submission was received.
What is the product code of K221706?
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.