510(k) · Cleared
Recalled · 2010Impax MA3000 Diagnostic Pacs Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare Corporation · LLZ System, Image Processing, Radiological
Cleared on Jul 28, 2008 as substantially equivalent to K040555 (Agfa Corp., 2004) and 1 other predicate after a 17-day review. Its family tree reaches back 5 generations to 1991. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 28, 2008
- Review
- 17 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913770 (1991). 13 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 1 generation backK040555 Impax Client EmbraceAgfa Corp. · 2004 · Recalled
- This deviceK081976 Impax MA3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation · 2008
- Descendant · cites it directly · 2 of its ownK111945 Impax Next GenerationAgfa Healthcare N.V. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- Descendant · 3 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · cites it directly · 0 of its ownK120305 Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet…Thinking Systems Corp. · 2012
Most influential descendants
Showing 4 of 4 · See all- K111945Impax Next GenerationAgfa Healthcare N.V. · 2011 · cites it directly2descendants
- K142316IMPAX AgilityAgfa Healthcare N.V. · 2015 · 2 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 3 generations on0descendants
- K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −1 | K040555 | Impax Client Embrace | Agfa Corp. | 2004 | 3 |
| 0 (this device) | K081976 | Impax MA3000 Diagnostic Pacs Workstation | Agfa Healthcare Corporation | 2008 | — |
| +1 | K111945 | Impax Next Generation | Agfa Healthcare N.V. | 2011 | 2 |
| +2 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| +3 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +1 | K120305 | Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet… | Thinking Systems Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K040555 | Impax Client EmbraceSummary page 1…and hardcopy reading and diagnosis by Radiologists. 5. Substantial Equivalence The predicate devices are: Agfa IMPAX Client Embrace Tm (later renamed MA3000), K040555, May 26, 2004. McKesson Medical Imaging Company, Horizon Medical Imaging, K043146, January 4, 2005.… | 2004 |
| * | K043146 | Horizon Medical ImagingSummary page 1…he predicate devices are: Agfa IMPAX Client Embrace Tm (later renamed MA3000), K040555, May 26, 2004. McKesson Medical Imaging Company, Horizon Medical Imaging, K043146, January 4, 2005. Page 1 of 3 6. Device Description IMPAX MA3000 is a dia… | 2005 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2010 | Not classified | Z-0835-2011 | Other | Product did not receive UL Certification |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K111945 (Agfa Healthcare N.V., 2011) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K040555.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 IMPAX MA3000 Diagnostic PACS Workstation is intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).
The IMPAX MA3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA cleared monitors and only when viewing Lossless format images.
The IMPAX MA3000 Diagnostic PACS Workstation is also intended for soft and hardcopy reading and diagnosis by Radiologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081976 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081976: Impax MA3000 Diagnostic 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/K081976
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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