Bellalun 2D (VDMS-1000S)
Device Facts
| Record ID | K254092 |
|---|---|
| Device Name | Bellalun 2D (VDMS-1000S) |
| Applicant | Vieworks Co., Ltd. |
| Product Code | MUE · Radiology |
| Decision Date | May 28, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1715 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”*See* § 892.1(e) for the availability of this guidance document.
