510(k) · Cleared
ClearedAbvs Workplace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · LLZ System, Image Processing, Radiological
Cleared on Sep 18, 2009 as substantially equivalent to K080930 (U-System, Inc., 2008) after a 71-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Sep 18, 2009
- Review
- 71 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922470 (1992). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 4 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 3 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 2 generations backK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- 1 generation backK080930 Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc. · 2008 · Recalled
- This deviceK092067 Abvs WorkplaceSiemens AG Medical Solutions · 2009
- Descendant · cites it directly · 1 of its ownK151075 BR-ABVS Viewer 1.0Taihao Medical, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK180641 Invenia ABUS ViewerGE Healthcare · 2018
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 |
|---|---|---|---|---|---|
| −5 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −4 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −3 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −2 | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| −1 | K080930 | Modification to Automated Breast Ultrasound System, Model Abus | U-System, Inc. | 2008 | 1 |
| 0 (this device) | K092067 | Abvs Workplace | Siemens AG Medical Solutions | 2009 | — |
| +1 | K151075 | BR-ABVS Viewer 1.0 | Taihao Medical, Inc. | 2016 | — |
| +2 | K180641 | Invenia ABUS Viewer | GE Healthcare | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 21.5 · 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 |
|---|---|---|---|
| * | K080930 | Modification to Automated Breast Ultrasound System, Model AbusSummary page 2…nufiacturer Predicate Device FDA Clearance Clearance Date Name Number U-systems Automated Breast K080930 08/07/2008 Ultrasou-nd System (ABUS) 21 DEPARTMEN… | 2008 |
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 |
|---|---|---|---|
| K151075 | BR-ABVS Viewer 1.0 | 2016 | 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 5 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K151075 (Taihao Medical, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ABVS Workplace is intended to display ultrasound images of the breast acquired from B-mode imaging using an automatic or handheld scanning linear transducer. The images may be reviewed and analyzed by the physician. The ABVS Workplace is indicated for use as an adjunct to mammography. The ABVS Workplace is not intended to be used as a replacement for screening mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092067: Abvs Workplace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092067
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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