Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bellalun 2D (VDMS-1000S)

K-Number: K254092 · 2026-05-28

ApplicantVieworks Co., Ltd.
Decision Date2026-05-28
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bellalun 2D (VDMS-1000S) 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 2026-05-28 under 510(k) number K254092. 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 Bellalun 2D (VDMS-1000S)?

Bellalun 2D (VDMS-1000S) is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K254092.

When did Bellalun 2D (VDMS-1000S) receive FDA 510(k) clearance?

Bellalun 2D (VDMS-1000S) received FDA 510(k) clearance on 2026-05-28, under 510(k) number K254092.

Who is the listed applicant for Bellalun 2D (VDMS-1000S)?

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 Bellalun 2D (VDMS-1000S)?

The FDA product code for Bellalun 2D (VDMS-1000S) 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)K251410VXvueK241113VIVIX-MK241125VIVIX-S 1751SK220239Solid State X-ray Imager(Model: FXRD-4386WB)K221512Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

View all 14 devices →

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.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence 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.

↑