510(k) · Cleared
ClearedAGFA HealthCare Enterprise Imaging
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 Oct 15, 2025 as substantially equivalent to K133135 (Agfa Healthcare N.V., 2014) and 2 other predicates after a 93-day review. Its family tree reaches back 12 generations to 1991. 3 of the 233 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 15, 2025
- Review
- 93 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K913770 (1991). 232 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 3 of the 233 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 2 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 1 generation backK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- This deviceK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 5 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 2 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 1 generation backK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- This deviceK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −2 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| −1 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| 0 (this device) | 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 |
| 1984 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 10 | 0 |
| 1998 | 17 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 19 | 0 |
| 2002 | 15 | 0 |
| 2003 | 11 | 0 |
| 2004 | 16 | 0 |
| 2005 | 16 | 0 |
| 2006 | 12 | 0 |
| 2007 | 10 | 1 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 1 |
| 2011 | 9 | 0 |
| 2012 | 5 | 1 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K133135 | Impax Volume Viewing 3.0Summary page 6…processing system Device Class: Class II Product Code: LLZ Predicate Devices This is a 510(k) for AGFA HealthCare Enterprise Imaging, it is substantially equivalent to K133135 – AGFA HealthCare’s IMPAX Volume Viewing (Primary Predicate), K142316 – AGFA HealthCare’s Enterprise Imaging Desktops, and K17043… | 2014 |
| * | K142316 | IMPAX AgilitySummary page 6…Devices This is a 510(k) for AGFA HealthCare Enterprise Imaging, it is substantially equivalent to K133135 – AGFA HealthCare’s IMPAX Volume Viewing (Primary Predicate), K142316 – AGFA HealthCare’s Enterprise Imaging Desktops, and K170434 – AGFA HealthCare’s Enterprise Imaging XERO Viewer. Device Descript… | 2015 |
| * | K170434 | Enterprise Imaging XERO Viewer 8.1Summary page 6…ing, it is substantially equivalent to K133135 – AGFA HealthCare’s IMPAX Volume Viewing (Primary Predicate), K142316 – AGFA HealthCare’s Enterprise Imaging Desktops, and K170434 – AGFA HealthCare’s Enterprise Imaging XERO Viewer. Device Description This premarket notification is for AFGA HealthCare’s Enter… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 5 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 57 of the 232 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K133135.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Enterprise Imaging Desktops when deployed as a departmental Picture Archiving and Communications System (PACS) 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. Enterprise Imaging Desktops are intended to be used by trained healthcare…
Read the full statement (499 words)
Enterprise Imaging Desktops when deployed as a departmental Picture Archiving and Communications System (PACS)
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. Enterprise Imaging Desktops are 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, image
registration and segmentation 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, Enterprise Imaging Desktops integrates with servers, archives, Radiology Information
Systems (RIS), Cardiology Information Systems (CIS), Hospital Information Systems (HIS), Electronic Patient Records
(EPR), 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.
When deployed as a hospital-wide Solution (Enterprise Imaging for Multispecialty Departments), Agfa HealthCare’s
Enterprise Imaging Desktops provides order generation, image acquisition, quality control, image reading, reporting, and
review workflows for departments that have no such systems available including (but not limited to) dermatology,
ophthalmology, gastroenterology, dental and general hospital use.
AGFA HealthCare’s Enterprise Imaging XERO Viewer is a software application used for reference and diagnostic
viewing of multispecialty medical imaging and non-imaging data with associated reports and documents and, as such,
fulfills a key role in the Enterprise Imaging solution. XERO Viewer enables healthcare professionals, including (but not
limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from
multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer allows users to perform
image manipulations (including window/level, markups, 3D visualization) and measurements.
When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to
determine if the image quality is suitable for their clinical application. 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 their intended use.
XERO Viewer can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review
and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not
intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO
Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252199: AGFA HealthCare Enterprise Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252199
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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