510(k) · Cleared
Recalled · 2007WEB1000
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 Dec 22, 2005 as substantially equivalent to K043415 (Ge Medical Systems Information Technologies, 2005) after a 9-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 22, 2005
- Review
- 9 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913770 (1991). 9 ancestors in all. 5 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 backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- This deviceK053458 WEB1000Agfa Corp. · 2005
- Descendant · cites it directly · 3 of its ownK133135 Impax Volume Viewing 3.0Agfa Healthcare N.V. · 2014
- Descendant · 2 generations on · 1 of its ownK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- Descendant · 2 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · 2 generations on · 0 of its ownK161061 IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016
- Descendant · cites it directly · 0 of its ownK071297 Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp. · 2007 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K133135Impax Volume Viewing 3.0Agfa Healthcare N.V. · 2014 · cites it directly3descendants
- K142316IMPAX AgilityAgfa Healthcare N.V. · 2015 · 2 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 2 generations on0descendants
- K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016 · 2 generations on0descendants
- K071297Impax SE Sigmacom Client (Pacs Workstation)Agfa Healthcare Corp. · 2007 · 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 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| 0 (this device) | K053458 | WEB1000 | Agfa Corp. | 2005 | — |
| +1 | K133135 | Impax Volume Viewing 3.0 | Agfa Healthcare N.V. | 2014 | — |
| +2 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| +2 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +2 | K161061 | IMPAX Volume Viewing 4.0 | Agfa Healthcare N.V. | 2016 | — |
| +1 | K071297 | Impax SE Sigmacom Client (Pacs Workstation) | Agfa Healthcare Corp. | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K043415 | Centricity Pacs SystemSummary page 1…ntial Equivalence The predicate device is General Electric Medical Systems' CentriCity TM RAGs System (Web Client Component) - a Class 11device (FDA's Clearance number: K043415; FDA's clearance date: January 21, 2005) 6. Device Description WEB1 000 TM is a software package, which may be marketed a… | 2005 |
What descends from it? (5)
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 |
|---|---|---|---|---|
| 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 14 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K133135 (Agfa Healthcare N.V., 2014) has gone furthest, with 3 descendants of its own.
- 10 other devices also cite its predicate K043415.
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?
AGFA's WEB1000 software is intended for installation on standard hardware meeting or exceeding minimum specifications. The system is intended for viewing, assembling, organizing, sharing, and displaying patient images and demographic information. The WEB1000 can be part of your evolving department solution and can also be used remotely over a hospital intranet or over the Internet.
When used by trained and qualified professionals the WEB1000 may be used for reviewing and referral purposes of medical image data collected from various types of modalities, including mammography. When used for mammography the WEB1000 should never be used as a diagnostic tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053458: WEB1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053458
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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