AccuCheck
FDA 510(k) K250696 · Manteia Technologies Co., Ltd.
510(k) numberK250696
Submission
- Device name
- AccuCheck
- Applicant
- Manteia Technologies Co., Ltd.
Xiamen, CN - Received
- March 7, 2025
- Decision date
- October 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Varian Medical Systems, Inc.
| 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 |
| K223834 | AccuCheckIYE · Traditional | 07/20/2023SE |
| K223724 | Mozi TPSMUJ · Traditional | 07/10/2023SE |
| K221706 | AccuContourQKB · Traditional | 03/09/2023SE |
Questions and answers
When was AccuCheck cleared by the FDA?
AccuCheck (K250696) received a 510(k) decision of Substantially Equivalent on October 24, 2025, 231 days after the submission was received.
What is the product code of K250696?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.