510(k) · Cleared
ClearedIMPAX Agility
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 Jan 6, 2015 as substantially equivalent to K111945 (Agfa Healthcare N.V., 2011) and 2 other predicates after a 140-day review. Its family tree reaches back 11 generations to 1991. 3 of the 205 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 6, 2015
- Review
- 140 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K913770 (1991). 203 ancestors in all, the oldest K837107 (1983). 1 later device descends from it, 1 citing it directly. 3 of the 205 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 1 generation backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- This deviceK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- Descendant · cites it directly · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 9 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 8 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 7 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 6 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 5 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 4 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 1 generation backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- This deviceK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −9 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −8 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −7 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −6 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −5 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −1 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| 0 (this device) | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| +1 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 14 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 19 | 0 |
| 2002 | 15 | 0 |
| 2003 | 8 | 0 |
| 2004 | 16 | 0 |
| 2005 | 15 | 0 |
| 2006 | 10 | 0 |
| 2007 | 10 | 1 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 1 |
| 2011 | 6 | 0 |
| 2012 | 3 | 1 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K111945 | Impax Next GenerationSummary page 4…510(k) for Agfa’s IMPAX Agility software, a picture archiving and communications system. It is substantially equivalent to systems with Agfa’s IMPAX Next Generation (K111945), Agfa’s IMPAX Volume Viewing 3.0 (K133135), and Siemens’ Syngo.via (K123920). B. DEVICE DESCRIPTION Agfa’s IMPAX Agility s… | 2011 |
| * | K133135 | Impax Volume Viewing 3.0Summary page 4…a picture archiving and communications system. It is substantially equivalent to systems with Agfa’s IMPAX Next Generation (K111945), Agfa’s IMPAX Volume Viewing 3.0 (K133135), and Siemens’ Syngo.via (K123920). B. DEVICE DESCRIPTION Agfa’s IMPAX Agility system is a picture archiving and communicat… | 2014 |
| * | K123920 | Syngo.ViaSummary page 4…ions system. It is substantially equivalent to systems with Agfa’s IMPAX Next Generation (K111945), Agfa’s IMPAX Volume Viewing 3.0 (K133135), and Siemens’ Syngo.via (K123920). B. DEVICE DESCRIPTION Agfa’s IMPAX Agility system is a picture archiving and communication system (PACS), product code LL… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252199 | AGFA HealthCare Enterprise Imaging | 2025 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 51 of the 203 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K252199 (Agfa Healthcare N.V., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
IMPAX Agility is a 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 Agility is intended to be used by trained healthcare professionals including, but not limited to physicians…
Read the full statement (204 words)
IMPAX Agility is a 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 Agility is intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic 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. Automatic spine labelling provides the capability to semi-automatically label vertebrae or disks.
As a comprehensive imaging suite, IMPAX Agility 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/K142316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142316: IMPAX Agility.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142316
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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