510(k) · Cleared
ClearedWebpax, Model 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heart Imaging Technologies, LLC · LLZ System, Image Processing, Radiological
Cleared on Jun 15, 2005 as substantially equivalent to K042203 (Siemens Medical Solutions USA, Inc., 2004) after a 26-day review. Its family tree reaches back 3 generations to 2001. 23 later devices descend from it.
- Decided
- Jun 15, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010938 (2001). 23 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 2 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 1 generation backK042203 Leonardo Syngo Cardiology WorkstationSiemens Medical Solutions USA, Inc. · 2004
- This deviceK051325 Webpax, Model 200Heart Imaging Technologies, LLC · 2005
- Descendant · cites it directly · 21 of its ownK092915 Cedara Webaccess, Model: 2.4Cedara Software Corp. · 2010 · Recalled
- Descendant · 2 generations on · 16 of its ownK111892 Vitreaview Software 6.1Vital Images, Inc. · 2011
- Descendant · 3 generations on · 15 of its ownK122136 VitreaviewVital Images, Inc. · 2012
- Descendant · 4 generations on · 8 of its ownK150738 VitreaViewVital Images, Inc. · 2015
- Descendant · 5 generations on · 7 of its ownK163232 Vitrea ViewVital Images, Inc. · 2017
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K092915Cedara Webaccess, Model: 2.4Cedara Software Corp. · 2010 · cites it directly21descendants
- K111892Vitreaview Software 6.1Vital Images, Inc. · 2011 · 2 generations on16descendants
- K122136VitreaviewVital Images, Inc. · 2012 · 3 generations on15descendants
- K150738VitreaViewVital Images, Inc. · 2015 · 4 generations on8descendants
- K163232Vitrea ViewVital Images, Inc. · 2017 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −2 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −1 | K042203 | Leonardo Syngo Cardiology Workstation | Siemens Medical Solutions USA, Inc. | 2004 | — |
| 0 (this device) | K051325 | Webpax, Model 200 | Heart Imaging Technologies, LLC | 2005 | — |
| +1 | K092915 | Cedara Webaccess, Model: 2.4 | Cedara Software Corp. | 2010 | 4 |
| +2 | K111892 | Vitreaview Software 6.1 | Vital Images, Inc. | 2011 | — |
| +3 | K122136 | Vitreaview | Vital Images, Inc. | 2012 | — |
| +4 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| +5 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K042203 | Leonardo Syngo Cardiology WorkstationSummary page 1…PACS) Regulation Number: 892.2050 Device Class: II Product Code: LLZ 51 Ok Number: K042203 (4) Description of Device WebPAX is an integrated software and hardware package capable of communicating and stori… | 2004 |
What descends from it? (23)
See all 232 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K092915 (Cedara Software Corp., 2010) has gone furthest, with 21 descendants of its own.
- 4 other devices also cite its predicate K042203.
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?
WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use in viewing medical images and making geometric measurements on medical images over the world wide web.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051325: Webpax, Model 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051325
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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