510(k) · Cleared
ClearedEchovacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vmi Technologies · LLZ System, Image Processing, Radiological
Cleared on Jul 14, 1997 as substantially equivalent to K963610 (A.L.I. Technologies, Inc., 1996) after a 62-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- Jul 14, 1997
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955092 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
- 1 generation backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
- This deviceK971776 EchovacsVmi Technologies · 1997
- Descendant · cites it directly · 1 of its ownK990052 Tel-Echo SystemInnovative Medical Solutions, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK032324 EchoencoderIcardiogram, Incorporated · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive… | Cemax-Icon, Inc. | 1996 | — |
| −1 | K963610 | Aki Compacs Data Compresion Module for Diagnostic Images | A.L.I. Technologies, Inc. | 1996 | — |
| 0 (this device) | K971776 | Echovacs | Vmi Technologies | 1997 | — |
| +1 | K990052 | Tel-Echo System | Innovative Medical Solutions, Inc. | 1999 | — |
| +2 | K032324 | Echoencoder | Icardiogram, Incorporated | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K963610 | Aki Compacs Data Compresion Module for Diagnostic ImagesSummary page 2…d Review stations by providing centralized functionality such as the storage of patient demographics. EchoVACS™ is substantially equivalent to the ALI UltraPACS system (K963610). Comparisons to Predicate Device The user features of ECchoVACS™ and ALI UltraPACS system (K963610) are very similar. EchoVAC… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990052 | Tel-Echo System | 1999 | 1 |
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 1 year and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K990052 (Innovative Medical Solutions, Inc., 1999) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K963610.
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?
EchoVACS™ is indicated for the capture, archiving, retrieval and display of echocardiography images. It permits annotation of images as well as recording and analysis of workload statistics. It also permits report generation from a comprehensive internal lexicon of anatomic and diagnostic terms covering adult, pediatric and fetal 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/K971776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971776: Echovacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971776
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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