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FDA 510(k)

2430TCA with Xmaru W

K-Number: K243849 · 2025-03-12

ApplicantRayence Co., Ltd.
Decision Date2025-03-12
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

2430TCA with Xmaru W is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K243849. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2430TCA with Xmaru W?

2430TCA with Xmaru W is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K243849.

When did 2430TCA with Xmaru W receive FDA 510(k) clearance?

2430TCA with Xmaru W received FDA 510(k) clearance on 2025-03-12, under 510(k) number K243849.

Who is the listed applicant for 2430TCA with Xmaru W?

The FDA 510(k) record lists Rayence Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2430TCA with Xmaru W?

The FDA product code for 2430TCA with Xmaru W is MUE.

Other records listing Rayence Co., Ltd. as applicant

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Related Devices (Code: MUE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K241113VIVIX-MVieworks Co., Ltd.K233539MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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