FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Bellalun 2D (VDMS-1000S)
K Number: K254092
·
Decision May 28, 2026
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
54
Applicant Total
21
Review Days
160
Basic Information
- Device Name
- Bellalun 2D (VDMS-1000S)
- K Number
- K254092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vieworks Co., Ltd.
- Date Received
- December 19, 2025
- Decision Date
- May 28, 2026
- Product Code
- MUE
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |
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|---|---|---|---|
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| K241125 | VIVIX-S 1751S | Nov 15, 2024 | Substantially Equivalent |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | Sep 13, 2022 | Substantially Equivalent |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Jul 20, 2022 | Substantially Equivalent |
| K200418 | VIVIX-S VW | Mar 18, 2020 | Substantially Equivalent |
| K190611 | VIVIX-S 1751S | Apr 8, 2019 | Substantially Equivalent |
| K181003 | VIVIX-S 1717V | May 15, 2018 | Substantially Equivalent |
| K163703 | VIVIX-S 1417N | Feb 8, 2017 | Substantially Equivalent |