2430TCA with Xmaru W
FDA 510(k) K243849 · Rayence Co., Ltd.
510(k) numberK243849
Submission
- Device name
- 2430TCA with Xmaru W
- Applicant
- Rayence Co., Ltd.
Hwaseong-Si, KR - Received
- December 16, 2024
- Decision date
- March 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K241113 | Vivix-MMUE · Traditional | Vieworks Co., Ltd. | 01/16/2025SE |
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More from Fujifilm Corporation
| 510(k) | Device | Decision |
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| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | 07/31/2026SE |
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| K240371 | 0909FCC, 0909FCC-HSMQB · Special | 03/07/2024SE |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GFMQB · Special | 06/21/2023SE |
| K220689 | Vatech ClismileNJM · Traditional | 05/06/2022SE |
| K212753 | 0909FCB, 1212FCAMQB · Special | 10/18/2021SE |
| K202902 | 2430MCA with Xmaru WMUE · Traditional | 06/21/2021SE |
| K210985 | 1717FCCMQB · Special | 04/28/2021SE |
| K202722 | 1212FCAMQB · Special | 10/26/2020SE |
| K201796 | 1717SCV, 1717SGVMQB · Special | 07/23/2020SE |
Questions and answers
When was 2430TCA with Xmaru W cleared by the FDA?
2430TCA with Xmaru W (K243849) received a 510(k) decision of Substantially Equivalent on March 12, 2025, 86 days after the submission was received.
What is the product code of K243849?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.