DeviceClearance

Bellalun 2D (VDMS-1000S)— 510(k) K254092

Substantially Equivalent

Vieworks Co., Ltd.

FDA 510(k) clearance K254092 for Bellalun 2D (VDMS-1000S), Substantially Equivalent on 2026-05-28. Applicant: Vieworks Co., Ltd.. Device class: 2.

Summary

Vieworks filed the Bellalun 2D (VDMS-1000S) under MUE, full field digital mammographic x-ray systems.

Class II, 21 CFR 892.1715. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).

Vieworks is in Anyang-Si, South Korea. Review took 160 calendar days (December 19, 2025 to May 28, 2026).

Clearance details

Applicant
Vieworks Co., Ltd.
Product code
Product code MUE
Device class
Class 2
Regulation
21 CFR 892.1715
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Anyang-Si, KR
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MUE

product code MUE
Death
5
Other
1
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.