510(k) · Cleared
Recalled · 2011Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corp. · LLZ System, Image Processing, Radiological
Cleared on Sep 12, 2002 as substantially equivalent to K973983 (Philips Medical Systems, Inc., 1998) and 1 other predicate after a 59-day review. Its family tree reaches back 3 generations to 1991. 48 later devices descend from it. It has been recalled 9 times.
- Decided
- Sep 12, 2002
- Review
- 59 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913475 (1991). 6 ancestors in all. 48 later devices descend from it, 12 citing it directly.
- Root · 3 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 2 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 1 generation backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- This deviceK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002
- Descendant · cites it directly · 14 of its ownK061421 Erad PacsErad, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK050228 Agfa Heartlab CardiovascularHeartlab, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 7 of its ownK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · cites it directly · 6 of its ownK143397 ICIS ViewAgfa Healthcare N.V. · 2015
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K061421Erad PacsErad, Inc. · 2006 · cites it directly14descendants
- K050228Agfa Heartlab CardiovascularHeartlab, Inc. · 2005 · cites it directly9descendants
- K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012 · 2 generations on7descendants
- K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · 2 generations on7descendants
- K143397ICIS ViewAgfa Healthcare N.V. · 2015 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −2 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −1 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for… | Agfa Corp. | 2002 | — |
| +1 | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| +1 | K050228 | Agfa Heartlab Cardiovascular | Heartlab, Inc. | 2005 | 22 |
| +2 | K120995 | Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product | Erad, Inc. | 2012 | — |
| +2 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| +1 | K143397 | ICIS View | Agfa Healthcare N.V. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K973983 | Phillips Easy Vision Family Workstation Option Endo 3DSummary page 2…. Legally Marketed Predicate Devices The legally marketed predicate devices are the Philips EasyVision workstations with Endo-3D option (cleared on January 8,1998 as K973983) and Quantitative Analysis option (cleared on January 30,1998 as K971965). 8. Device Description The predicate devices and… | 1998 |
| * | K971965 | Philips EasyvisionSummary page 2…evices are the Philips EasyVision workstations with Endo-3D option (cleared on January 8,1998 as K973983) and Quantitative Analysis option (cleared on January 30,1998 as K971965). 8. Device Description The predicate devices and IMPAX@Workstations with MPR, Digital Subtraction and 3D options are medic… | 1998 |
What descends from it? (48)
See all 4812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061421 | Erad Pacs | 2006 | 14 |
| K050228 | Agfa Heartlab Cardiovascular | 2005 | 9 |
| K143397 | ICIS View | 2015 | 6 |
| K133135 | Impax Volume Viewing 3.0 | 2014 | 3 |
| K111945 | Impax Next Generation | 2011 | 2 |
| K062878 | Ezpacs, Version 3.0 | 2007 | 2 |
| K040344 | Impax OT3000 Orthopedic Workstation | 2004 | 2 |
| K040896 | Modification to Encompass | 2004 | 1 |
| K031132 | Consultiva Case Input Station, Model Cis-1 | 2003 | 1 |
| K031248 | Consultiva Report Station, Model RS-1 | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2011 | Not classified | Z-2246-2011 | Other | Software issue that occurs after dictation of a study. |
| Jul 16, 2009 | Not classified | Z-1887-2009 | Software design | Measurements are inaccurate on multiple workstations. |
| Dec 24, 2008 | Not classified | Z-0945-2009 | Software design | Polling procedure may fail when multiple merge/split is carried out. |
| Jun 4, 2008 | Not classified | Z-2180-2008 | Software design | The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study. |
| May 14, 2007 | Not classified | Z-1243-2008 | Software change control | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. |
| May 14, 2007 | Not classified | Z-1244-2008 | Software change control | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. |
| Feb 15, 2007 | Not classified | Z-1307-2008 | Software design | Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient. |
| Aug 8, 2006 | Not classified | Z-0033-2007 | Other | Failed CAD displayed as 'No Findings' |
| Jun 30, 2006 | Not classified | Z-1256-06 | Other | Possible corrupted image appearing after System Start. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K061421 (Erad, Inc., 2006) has gone furthest, with 14 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.
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@Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information. MPR and 3D functions…
Read the full statement (104 words)
IMPAX@Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information.
They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information.
MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022292
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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