# K254092: Bellalun 2D (VDMS-1000S)

- Pathway: 510(k) (Traditional)
- Applicant: Vieworks Co., Ltd.
- Decided: May 28, 2026 after 160 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P990066 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220073: RMF-2000, DRTECH Corporation (2023) Summary page 5.

## Indications for use
VDMS-1000S is intended for generating mammographic images that can be used for screening and diagnosis of breast cancer. It can be used to acquire 2D digital mammograms in the same clinical applications as traditional film/screen systems.

Source page: https://510kreport.com/device/K254092
Methodology: https://510kreport.com/methodology