510(k) · Cleared
Recalled · 2007Impax Client Embrace
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 May 26, 2004 as substantially equivalent to K033400 (Ge Medical Systems W-400, 2003) after an 85-day review. Its family tree reaches back 4 generations to 1991. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- May 26, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913770 (1991). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- This deviceK040555 Impax Client EmbraceAgfa Corp. · 2004
- Descendant · cites it directly · 4 of its ownK081976 Impax MA3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK111945 Impax Next GenerationAgfa Healthcare N.V. · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- Descendant · 4 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · 2 generations on · 0 of its ownK120305 Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet…Thinking Systems Corp. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K081976Impax MA3000 Diagnostic Pacs WorkstationAgfa Healthcare Corporation · 2008 · cites it directly4descendants
- K111945Impax Next GenerationAgfa Healthcare N.V. · 2011 · 2 generations on2descendants
- K142316IMPAX AgilityAgfa Healthcare N.V. · 2015 · 3 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 4 generations on0descendants
- K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| 0 (this device) | K040555 | Impax Client Embrace | Agfa Corp. | 2004 | — |
| +1 | K081976 | Impax MA3000 Diagnostic Pacs Workstation | Agfa Healthcare Corporation | 2008 | 1 |
| +2 | K111945 | Impax Next Generation | Agfa Healthcare N.V. | 2011 | 2 |
| +3 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| +4 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K033400 | Seno AdvantageSummary page 1…i.e. Breast MR and Breast US). 5. Substantial Equivalence The predicate devices is General Electric Medical Systems' Seno Advantage (FDA's Clearance number: K033400; FDA's clearance date: 12/04/2003). 6. Device Description IMPAX Client EmbraceTM i delivers a diagnostic softcopy breast im… | 2003 |
What descends from it? (6)
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 |
|---|---|---|---|---|
| Jun 28, 2007 | Not classified | Z-1245-2008 | Software design | Text and Images may not be synchronized. |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K081976 (Agfa Healthcare Corporation, 2008) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K033400.
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?
The Embrace TM DS3000 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 Embrace TM DS3000 Diagnostic PACS Workstation when intended for
diagnostic/screening Mammography viewing must do so only when used with
FDA approved monitors and only when viewing Lossless format images.
The Embrace TM DS3000 Diagnostic PACS Workstation is also intended for
softcopy reading and diagnosis by Radiologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040555: Impax Client Embrace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040555
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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