← Product Code [MUE](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE) · K254092

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

_Vieworks Co., Ltd. · MUE · May 28, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K254092

## Device Facts

- **Applicant:** Vieworks Co., Ltd.
- **Product Code:** [MUE](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE.md)
- **Decision Date:** May 28, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1715
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K254092](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MUE/K254092)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com