Cleared Traditional

K254092 - Bellalun 2D (VDMS-1000S)

K254092 is an FDA 510(k) clearance for Bellalun 2D (VDMS-1000S), manufactured by Vieworks Co., Ltd.. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K254092 · Vieworks Co., Ltd. · Radiology device
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May 2026
Decision
160d
Days
Class 2
Risk

K254092 is an FDA 510(k) clearance for the Bellalun 2D (VDMS-1000S). Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Vieworks Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on May 28, 2026 after a review of 160 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1715 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vieworks Co., Ltd. devices

FDA 510(k) Submission Details - K254092

510(k) Number K254092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date May 28, 2026
Days to Decision 160 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 107d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUE Device Classification - Class 2, Special Controls

Product Code MUE Full Field Digital, System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1715
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUE Full Field Digital, System, X-ray, Mammographic

All 54
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