510(k) · Cleared
ClearedEtiam Pacs Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etiam S.A.S.U. · LLZ System, Image Processing, Radiological
Cleared on May 29, 2013 as substantially equivalent to K052358 (Etiam, S.A., 2005) and 2 other predicates after a 15-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- May 29, 2013
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K942120 (1994). 14 ancestors in all, the oldest K896095 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 4 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 3 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 2 generations backK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- 1 generation backK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- This deviceK131392 Etiam Pacs ComponentsEtiam S.A.S.U. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −5 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −4 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −3 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −2 | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| −1 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| 0 (this device) | K131392 | Etiam Pacs Components | Etiam S.A.S.U. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K052358 | Etiam Star Pacs ComponentsSummary page 2…www.etiam.com - Secure Medical Networking IPredicate De vices: 21 CFR 807. E2&() o 510(k) number K052358 Regulation number 892.2050 Device name ETIAM STAR PACS COMPONENTS App… | 2005 |
| * | K062488 | IQ-System Pacs SystemSummary page 2…AGE PROCESSING, RADIOLOGICAL Class II Panel Radiology Device o 510(k) number K062488 Regulation number 892.2050 Device name iQ-System PACS Applicant… | 2006 |
| * | K083618 | Pacs ScanSummary page 2…AGE PROCESSING, RADIOLOGICAL Class II Panel Radiology Device o 510(k) number K083618 Regulation number 892.2050 Device name PACS SCAN Applicant… | 2009 |
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 19 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- None of the 14 ancestors has a recall.
- 1 other device also cites its predicate K052358.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
ETIAM PACS Components TM is intended to be used by healthcare personnel to import, review, edit and send medical images. ETIAM PACS Components TM is not labeled for diagnostic use. ETIAM 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…
Read the full statement (123 words)
ETIAM PACS Components TM is intended to be used by healthcare personnel to import, review, edit and send medical images.
ETIAM PACS Components TM is not labeled for diagnostic use.
ETIAM 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131392: Etiam 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/K131392
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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