510(k) · Cleared
Recalled · Class II · 2013Impax SE Sigmacom Client (Pacs Workstation)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare Corp. · LLZ System, Image Processing, Radiological
Cleared on Jun 22, 2007 as substantially equivalent to K050751 (Agfa Corp., 2005) and 2 other predicates after a 44-day review. Its family tree reaches back 6 generations to 1991. It has been recalled once.
- Decided
- Jun 22, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913770 (1991). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 1 generation backK053458 WEB1000Agfa Corp. · 2005 · Recalled
- This deviceK071297 Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| −1 | K053458 | WEB1000 | Agfa Corp. | 2005 | 2 |
| 0 (this device) | K071297 | Impax SE Sigmacom Client (Pacs Workstation) | Agfa Healthcare Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K050751 | Impax Orthopaedic Workstation, Model Impax ES 5.XSummary page 1…s is a 510(k) for Agfa's Impax SE SigmaCom Client (PACS Medical Imaging Display Workstation). The predicate devices are Agfa's previous earlier workstations, the OT3000 (K050751), the Embrace (mammography) workstation (K040555) and the Web1000 remote access workstation (K053458). This new device includes m… | 2005 |
| * | K040555 | Impax Client EmbraceSummary page 1…(PACS Medical Imaging Display Workstation). The predicate devices are Agfa's previous earlier workstations, the OT3000 (K050751), the Embrace (mammography) workstation (K040555) and the Web1000 remote access workstation (K053458). This new device includes most of the clinical functions of the predicate de… | 2004 |
| * | K053458 | WEB1000Summary page 1…dicate devices are Agfa's previous earlier workstations, the OT3000 (K050751), the Embrace (mammography) workstation (K040555) and the Web1000 remote access workstation (K053458). This new device includes most of the clinical functions of the predicate devices but was developed by Agfa HealthCare Enterpris… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2013 | Class II | Z-0035-2014 | Software in the Use Environment | System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K050751.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 system is indicated for the storage, reading, interpretation, clinical review, analysis, annotation, distribution, printing, editing and processing of digital images and data acquired from any DICOM device by healthcare professionals, including radiologists, physicians, technologists and clinicians. - With the Teleradiology option it can be used to consult and share information with remote users. - With the Mammography option it can be used for…
Read the full statement (151 words)
The system is indicated for the storage, reading, interpretation, clinical review, analysis, annotation, distribution, printing, editing and processing of digital images and data acquired from any DICOM device by healthcare professionals, including radiologists, physicians, technologists and clinicians.
- With the Teleradiology option it can be used to consult and share information with remote users.
- With the Mammography option it can be used for screening and diagnosis (with MG, "For presentation" images only) from FDA approved modalities in softcopy and printed formats.
- With the Orthopedic option it can be used to perform common orthopedic measurements of the hip, knee, spine (Coxometry, Gonometry, Lipman Cobb).
- With the Slice Imaging option it can be used to process basic 3D rendering: MIP, MPR or series synchronization.
- With the Quality Assurance option it can be used by PACS administrators or technologists to perform quality control activities related to patient images and data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071297: Impax SE Sigmacom Client (Pacs Workstation).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071297
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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