510(k) · Cleared
ClearedEtiam Star Pacs Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etiam, S.A. · LLZ System, Image Processing, Radiological
Cleared on Oct 5, 2005 as substantially equivalent to K042313 (Dynamic Imaging, Inc., 2004) after a 37-day review. Its family tree reaches back 4 generations to 1994. 56 later devices descend from it.
- Decided
- Oct 5, 2005
- Review
- 37 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K942120 (1994). 7 ancestors in all. 56 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 3 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 2 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 1 generation backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- This deviceK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- Descendant · cites it directly · 55 of its ownK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- Descendant · 2 generations on · 49 of its ownK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- Descendant · 3 generations on · 44 of its ownK101342 Osirix MDPixmeo Sarl · 2010
- Descendant · 4 generations on · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 5 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K062488IQ-System Pacs SystemImage Information Systems, Ltd. · 2006 · cites it directly55descendants
- K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007 · 2 generations on49descendants
- K101342Osirix MDPixmeo Sarl · 2010 · 3 generations on44descendants
- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · 4 generations on31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 5 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −3 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −2 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −1 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| 0 (this device) | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| +1 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| +2 | K063470 | Aycan Workstation Osirix | Aycan Digitalsysteme GmbH | 2007 | — |
| +3 | K101342 | Osirix MD | Pixmeo Sarl | 2010 | — |
| +4 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +5 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 8 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K042313 | Integradweb MPR/MipSummary page 1…lassification: 892.2050 System. Image Processing Product Code: LLZ Predicate Device: 21 CFR 807. 92(a)(3) 510(k) Number K042313 Regulation Number 892.2050 Device Name INTEGRADWEB MPR/MIP Applicant… | 2004 |
What descends from it? (56)
See all 562 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K062488 (Image Information Systems, Ltd., 2006) has gone furthest, with 55 descendants of its own.
- 5 other devices also cite its predicate K042313.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ETIAM STAR PACS Components TM is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA…
Read the full statement (101 words)
ETIAM STAR PACS Components TM is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052358: Etiam Star Pacs Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052358
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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