510(k) · Cleared
ClearedShowcase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trillium Technology, Inc. · LLZ System, Image Processing, Radiological
Cleared on Oct 21, 2008 as substantially equivalent to K020995 (Efilm Medical, Inc., 2002) and 2 other predicates after an 84-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Oct 21, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K935595 (1995). 60 ancestors in all, the oldest K891449 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 6 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 5 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 4 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 3 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 2 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 1 generation backK060992 Syngo US WorkplaceSiemens Medical Solutions · 2006 · Recalled
- This deviceK082135 ShowcaseTrillium Technology, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −7 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −6 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −5 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −4 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −3 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −2 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −1 | K060992 | Syngo US Workplace | Siemens Medical Solutions | 2006 | 1 |
| 0 (this device) | K082135 | Showcase | Trillium Technology, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K020995 | Efilm Workstation with ModulesSummary page 1…Manufacturer Number Date Code eFilm TM Workstation with Modules, eFilm Medical Inc. K020995 04/12/2002 LLZ (became Merge eMed, Inc.) Premarket Submission 510(k) Trillium Technology, Inc.… | 2002 |
| * | K060992 | Syngo US WorkplaceSummary page 2…Section 2- 1 SHOWCASE syngo® Ultrasound Workplace, Siemens Medical Systems USA, Inc. K060992 04/28/2006 LLZ Ultrasound Division Volcano s5i Family of Imaging Systems, Volcano… | 2006 |
| * | K061215 | Volcano S51 Family of Imaging SystemsSummary page 2…USA, Inc. K060992 04/28/2006 LLZ Ultrasound Division Volcano s5i Family of Imaging Systems, Volcano CorporationK061215 Volcano Corporation 08/10/2006 LLZ 5- Device Description ShowCase is di… | 2006 |
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 13 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 12 of the 60 ancestors have a recall of any class.
- 14 other devices also cite its predicate K020995.
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?
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082135: Showcase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082135
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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