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FDA 510(k)

VIVIX-M

K-Number: K241113 · 2025-01-16

ApplicantVieworks Co., Ltd.
Decision Date2025-01-16
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VIVIX-M is the device name listed in this FDA 510(k) record. The listed applicant is Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K241113. 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 VIVIX-M?

VIVIX-M is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K241113.

When did VIVIX-M receive FDA 510(k) clearance?

VIVIX-M received FDA 510(k) clearance on 2025-01-16, under 510(k) number K241113.

Who is the listed applicant for VIVIX-M?

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

What is the FDA product code for VIVIX-M?

The FDA product code for VIVIX-M is MUE.

Other records listing Vieworks Co., Ltd. as applicant

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.

K260820VIVIX-S 4386W (FXRD-4386WA)K254092Bellalun 2D (VDMS-1000S)K251410VXvueK241125VIVIX-S 1751SK220239Solid State X-ray Imager(Model: FXRD-4386WB)K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

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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.K2438492430TCA with Xmaru WRayence 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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