510(k) · Cleared
ClearedBellalun 2D (VDMS-1000S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vieworks Co., Ltd. · MUE Full Field Digital, System, X-Ray, Mammographic
Cleared on May 28, 2026 as substantially equivalent to K220073 (DRTECH Corporation, 2023) after a 160-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- May 28, 2026
- Review
- 160 days
- Class
- Class II
- Product code
- MUE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P990066 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backP990066 GE Healthcare Senographe Full Field Digital Mammography SystemGE Healthcare · 2000 · Recalled
- 2 generations backK110798 Senographe DS, Senographe EssentialGeneral Electric Company · 2011
- 1 generation backK220073 RMF-2000DRTECH Corporation · 2023
- This deviceK254092 Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P990066 | GE Healthcare Senographe Full Field Digital Mammography System | GE Healthcare | 2000 | 4 |
| −2 | K110798 | Senographe DS, Senographe Essential | General Electric Company | 2011 | — |
| −1 | K220073 | RMF-2000 | DRTECH Corporation | 2023 | — |
| 0 (this device) | K254092 | Bellalun 2D (VDMS-1000S) | Vieworks Co., Ltd. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUE device
- #1 K253678 MAMMOMAT B.brilliant (11372950)score 13.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220073 | RMF-2000Summary page 5…uct Code: MUE Device Class: 2 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)] 510(k) Number: K220073 Applicant: DRTECH Corporation Trade Name: RMF-2000… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MUE devicesMUE Full Field Digital, System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MUE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUE
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUE
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUE
40in 2025
MAUDE reports naming product code MUE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | — | 0 | 0 |
| 2008 | 5 | — | 1 | 4 |
| 2009 | 8 | — | 1 | 3 |
| 2010 | 10 | — | 2 | 2 |
| 2011 | 10 | 192 | 5 | 10 |
| 2012 | 4 | 123 | 0 | 6 |
| 2013 | 7 | 207 | 0 | 11 |
| 2014 | 1 | — | 2 | 7 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 19 |
| 2017 | 8 | 95 | 6 | 115 |
| 2018 | 2 | — | 1 | 145 |
| 2019 | 2 | — | 1 | 80 |
| 2020 | 4 | 188 | 0 | 49 |
| 2021 | 4 | 164 | 0 | 25 |
| 2022 | 3 | 404 | 0 | 36 |
| 2023 | 1 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 3 | 255 | 4 | 40 |
| 2026 | 4 | 185 | 1 | — |
What is it indicated for?
VDMS-1000S is intended for generating mammographic images that can be used for screening and diagnosis of breast cancer. It can be used to acquire 2D digital mammograms in the same clinical applications as traditional film/screen systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254092 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254092: Bellalun 2D (VDMS-1000S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254092
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026