510(k) · Cleared
ClearedDexela Dex Top Mammography Workstation, Model Mamwkvi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexela, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 22, 2008 as substantially equivalent to K033400 (Ge Medical Systems W-400, 2003) after a 71-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Apr 22, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913770 (1991). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- This deviceK080351 Dexela Dex Top Mammography Workstation, Model MamwkviDexela, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK091368 R2 Digitalnow HD (Digitalnow HD)Hologic, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK123530 Mammography Prior Enhancement (Mpe)Hologic, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| 0 (this device) | K080351 | Dexela Dex Top Mammography Workstation, Model Mamwkvi | Dexela, Ltd. | 2008 | — |
| +1 | K091368 | R2 Digitalnow HD (Digitalnow HD) | Hologic, Inc. | 2009 | — |
| +2 | K123530 | Mammography Prior Enhancement (Mpe) | Hologic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.6 · 11 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 |
|---|---|---|---|
| * | K033400 | Seno AdvantageSummary page 1…SSIFICATION NAME: Picture Archiving and Communication System PREDICATE DEVICE(S): General Electric Medical Systems: Seno Advantage (K033400) DEVICE DESCRIPTION: The DexTop Mammography Workstation is a software product, which runs on a high end personal computer, for… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091368 | R2 Digitalnow HD (Digitalnow HD) | 2009 | 1 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K091368 (Hologic, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K033400.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The DexTop Mammography Workstation is a mammography review workstation software package, which provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar, medical image data. The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality soft-copy images with…
Read the full statement (208 words)
The DexTop Mammography Workstation is a mammography review workstation software package, which provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar, medical image data.
The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality soft-copy images with special emphasis and optimization for mammography.
Dexela DexTop Mammography Workstation will display the full fidelity DICOM image in a non-compressed format. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis.
Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 megapixel resolution and meets other technical specifications reviewed and accepted by the FDA
When interpreted by a skilled physician, this software provides information that may be useful in screening and diagnosis. However, the final judgment must rely on the knowledge and skill of the physician.
The device will display only DICOM "For Presentation" images for primary image diagnosis. The device does not perform any image processing (except simple manipulation such as gray scale changes by window level and window width) of the proprietary image processing algorithm of the FFDM manufacturers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080351 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080351: Dexela Dex Top Mammography Workstation, Model Mamwkvi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080351
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026