510(k) · Cleared
ClearedEchocardiography System Series 95000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camtronics, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 8, 1999 as substantially equivalent to K980060 (Mpacs, LLC, 1998) after a 64-day review. Its family tree reaches back 3 generations to 1995. 16 later devices descend from it.
- Decided
- Sep 8, 1999
- Review
- 64 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950279 (1995). 16 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 2 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
- 1 generation backK980060 EcholinkMpacs, LLC · 1998
- This deviceK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
- Descendant · cites it directly · 13 of its ownK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
- Descendant · 4 generations on · 5 of its ownK122205 EXINIExini Diagnostics AB · 2012
- Descendant · 2 generations on · 3 of its ownK050943 GE ViewpointGeneral Electric Co. · 2005 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K041029KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · cites it directly13descendants
- K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · 2 generations on7descendants
- K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · 3 generations on6descendants
- K122205EXINIExini Diagnostics AB · 2012 · 4 generations on5descendants
- K050943GE ViewpointGeneral Electric Co. · 2005 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −2 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| −1 | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| 0 (this device) | K992259 | Echocardiography System Series 95000 | Camtronics, Ltd. | 1999 | — |
| +1 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| +2 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| +3 | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
| +4 | K122205 | EXINI | Exini Diagnostics AB | 2012 | — |
| +2 | K050943 | GE Viewpoint | General Electric Co. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K980060 | EcholinkSummary page 1…chocardiography System Common name: Echocardiography System Classification name: Picture Archiving and Communications System Predicate substantially equivalent devices: K980060 MPACS, LLC “EchoLINK” Device description and intended use: The Echocardiography System provides a digital image transport and ar… | 1998 |
What descends from it? (16)
See all 163 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 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041029 (Siemens Medi Cal Solutions, Inc., 2004) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K980060.
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?
A digital image capture, storage, and review system for echocardiography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992259: Echocardiography System Series 95000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992259
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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