510(k) · Cleared
ClearedEcholink
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mpacs, LLC · LLZ System, Image Processing, Radiological
Cleared on Feb 25, 1998 as substantially equivalent to K964803 (Network Concepts, Inc., 1997) and 1 other predicate after a 49-day review. Its family tree reaches back 2 generations to 1995. 23 later devices descend from it.
- Decided
- Feb 25, 1998
- Review
- 49 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950279 (1995). 23 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
- 1 generation backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
- This deviceK980060 EcholinkMpacs, LLC · 1998
- Descendant · cites it directly · 16 of its ownK023772 Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · Recalled
- Descendant · cites it directly · 16 of its ownK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
- Descendant · 2 generations on · 13 of its ownK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K023772Kinetdx Picture Archiving and Communications SystemAcuson Corp. · 2002 · cites it directly16descendants
- K992259Echocardiography System Series 95000Camtronics, Ltd. · 1999 · cites it directly16descendants
- K041029KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · 2 generations on13descendants
- K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · 3 generations on7descendants
- K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950279 | TOMTECP90 | Tomtec Imaging Systems, Inc. | 1995 | — |
| −1 | K964803 | Univision Echocardiology System | Network Concepts, Inc. | 1997 | — |
| 0 (this device) | K980060 | Echolink | Mpacs, LLC | 1998 | — |
| +1 | K023772 | Kinetdx Picture Archiving and Communications System | Acuson Corp. | 2002 | 5 |
| +1 | K992259 | Echocardiography System Series 95000 | Camtronics, Ltd. | 1999 | — |
| +2 | K041029 | Kinetdx | Siemens Medi Cal Solutions, Inc. | 2004 | 1 |
| +3 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
| +4 | K111319 | Ibis Explorer and Markup Software | Medqia | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 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? (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 |
|---|---|---|---|
| * | K964803 | Univision Echocardiology SystemSummary page 2…6. Classification Panel: Radiology -8- MPACS. LLC E. Equivalent Devices The equivalent legally marketed devices are the UNIVISION system (510(k) Number K964803) manufactured by NCI (Network Concepts, Inc.) for routine echocardiography and the TomTec™° (510(k) Number K950279) manufactured… | 1997 |
| * | K950279 | TOMTECP90Summary page 2…rketed devices are the UNIVISION system (510(k) Number K964803) manufactured by NCI (Network Concepts, Inc.) for routine echocardiography and the TomTec™° (510(k) Number K950279) manufactured by TomTec Imaging Systems, Inc. for stress echocardiography. F. Device Description EchoLINK provides a telecardio… | 1995 |
What descends from it? (23)
See all 235 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 3 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K023772 (Acuson Corp., 2002) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K964803.
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?
This device is intended for use by health care professionals trained in the field of echocardiography or medical ultrasound. It is to be used when there is a need to convert ultrasound analog video to a digital video format for subsequent review and archiving. This device is also intended for use in transferring ultrasound images over digital networks and/or digital communication lines.
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/K980060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980060: Echolink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980060
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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