510(k) · Cleared
Recalled · Class II · 2018Impax Next Generation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare N.V. · LLZ System, Image Processing, Radiological
Cleared on Aug 5, 2011 as substantially equivalent to K022292 (Agfa Corp., 2002) and 2 other predicates after a 28-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 5, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913770 (1991). 31 ancestors in all, the oldest K904519 (1991). 2 later devices descend from it, 1 citing it directly.
- 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 backK040555 Impax Client EmbraceAgfa Corp. · 2004 · Recalled
- 1 generation backK081976 Impax MA3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation · 2008 · Recalled
- This deviceK111945 Impax Next GenerationAgfa Healthcare N.V. · 2011
- Descendant · cites it directly · 1 of its ownK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- Descendant · 2 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
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 |
|---|---|---|---|---|---|
| −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 | K040555 | Impax Client Embrace | Agfa Corp. | 2004 | 3 |
| −1 | K081976 | Impax MA3000 Diagnostic Pacs Workstation | Agfa Healthcare Corporation | 2008 | 1 |
| 0 (this device) | K111945 | Impax Next Generation | Agfa Healthcare N.V. | 2011 | — |
| +1 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| +2 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Summary page 1…ext Generation, which is a picture archiving and communications system. It is substantially equivalent to Agfa's IMPAX workstations with MPR, Digital Subtraction and 3D (K022292), and for orthopedic use to its Agfa Orthopedic Software for IMPAX Workstations (K07 1972), and for mammography to Agfa's IMPAX M… | 2002 |
| * | K071972 | Orthopedic Software for Impax WorkstationsSummary page 1…ly equivalent to Agfa's IMPAX workstations with MPR, Digital Subtraction and 3D (K022292), and for orthopedic use to its Agfa Orthopedic Software for IMPAX Workstations (K07 1972), and for mammography to Agfa's IMPAX MA3000 (KOS81976). B. DEVICE DESCRIPTION The new device is largely similar to the pre… | 2007 |
| * | K081976 | Impax MA3000 Diagnostic Pacs WorkstationSummary page 2…L EQUIVALENCE SUMMARY Agfa's IMPAX Next Generation has an Indications for Use statement largely similar to the statements for the predicate devices (K022292, K071972 and K08 1976). The statements have been combined and simplified. Intended uses are the same. The devices have the same technological character… | 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 |
|---|---|---|---|
| K142316 | IMPAX Agility | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2018 | Class II | Z-0101-2019 | Software design | Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thumbnail images of the studies are no… |
| Jan 8, 2014 | Class II | Z-0919-2014 | Unknown/Undetermined by firm | Patient name displayed (printed) on the Patient Report was the wrong patient name. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 10 of the 31 ancestors have a recall of any class.
- Of its descendants, K142316 (Agfa Healthcare N.V., 2015) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K022292.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Agfa's IMPAX Next Generation isa Picture Archiving and Communications System (PACS). It provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Next Generation isintended to be used by trained healthcare professionals including, but not…
Read the full statement (193 words)
Agfa's IMPAX Next Generation isa Picture Archiving and Communications System (PACS). It provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Next Generation isintended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedlic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data.
MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling and image registration can be used to enhance image viewing.
As acomprehensive imaging suite, IMPAX Next Generation integrates with servers, archives, Radiology Information Systems (RIS), Hospital Information Systems (HIS), reporting and 3rd party applications for customer specific workflows.
Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111945: Impax Next Generation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111945
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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