2430MCA with Xmaru W
FDA 510(k) K202902 · Rayence Co., Ltd.
510(k) numberK202902
Submission
- Device name
- 2430MCA with Xmaru W
- Applicant
- Rayence Co., Ltd.
Hwaseong-Si, KR - Received
- September 29, 2020
- Decision date
- June 21, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MUE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254090 | I-View®MUE · Traditional | Hologic, Inc. | 09/02/2026SE |
| K253678 | MAMMOMAT B.brilliant (11372950)MUE · Traditional | Siemens Medical Solutions USA, Inc. | 06/18/2026SE |
| K254092 | Bellalun 2D (VDMS-1000S)MUE · Traditional | Vieworks Co., Ltd. | 05/28/2026SE |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE · Traditional | GE Medical Systems SCS | 03/24/2026SE |
| K243420 | HestiaMUE · Traditional | Genoray Co., Ltd. | 07/17/2025SE |
| K243849 | 2430TCA with Xmaru WMUE · Special | Rayence Co., Ltd. | 03/12/2025SE |
| K241113 | Vivix-MMUE · Traditional | Vieworks Co., Ltd. | 01/16/2025SE |
| K233539 | MAMMOMAT B.brilliantMUE · Traditional | Siemens Medical Solutions USA, Inc. | 03/27/2024SE |
| K220073 | RMF-2000MUE · Traditional | DRTECH Corporation | 01/26/2023SE |
| K211720 | Planmed Clarity 2D, Planmed Clarify SMUE · Traditional | Planmed OY | 07/18/2022SE |
More from Planmed OY
| 510(k) | Device | Decision |
|---|---|---|
| K253800 | 0909FCE, 0909FCE-HSMQB · Traditional | 07/31/2026SE |
| K243849 | 2430TCA with Xmaru WMUE · Special | 03/12/2025SE |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)MQB · Traditional | 09/09/2024SE |
| 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 |
| K210985 | 1717FCCMQB · Special | 04/28/2021SE |
| K202722 | 1212FCAMQB · Special | 10/26/2020SE |
| K201796 | 1717SCV, 1717SGVMQB · Special | 07/23/2020SE |
Questions and answers
When was 2430MCA with Xmaru W cleared by the FDA?
2430MCA with Xmaru W (K202902) received a 510(k) decision of Substantially Equivalent on June 21, 2021, 265 days after the submission was received.
What is the product code of K202902?
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.