510(k) K254092
K254092 is an FDA 510(k) premarket notification submitted by Vieworks Co., Ltd. for the device "Bellalun 2D (VDMS-1000S)". The FDA issued a decision of Substantially Equivalent on May 28, 2026. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Vieworks Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2026
- Date Received
- December 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Full Field Digital, System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1715
- Review Panel
- RA
- Submission Type