DeepContour (V1.0)
FDA 510(k) K232928 · Wisdom Technologies., Inc.
510(k) numberK232928
Submission
- Device name
- DeepContour (V1.0)
- Applicant
- Wisdom Technologies., Inc.
Hefei, CN - Received
- September 20, 2023
- Decision date
- May 7, 2024
- 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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|---|---|---|---|
| K262452 | AutoContour (RADAC V6)QKB · Special | Radformation, Inc. | 08/14/2026SE |
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| K252548 | AI-Rad Companion Organs RTQKB · Traditional | Siemens Healthcare GmbH | 04/10/2026SE |
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| 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 |
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| K231273 | ArcherQA (V1.0)IYE · Traditional | 01/05/2024SE |
Questions and answers
When was DeepContour (V1.0) cleared by the FDA?
DeepContour (V1.0) (K232928) received a 510(k) decision of Substantially Equivalent on May 7, 2024, 230 days after the submission was received.
What is the product code of K232928?
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.