510(k) · Cleared
ClearedEchoencoder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icardiogram, Incorporated · LLZ System, Image Processing, Radiological
Cleared on Oct 2, 2003 as substantially equivalent to K990052 (Innovative Medical Solutions, Inc., 1999) and 1 other predicate after a 66-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Oct 2, 2003
- Review
- 66 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K955092 (1996). 7 ancestors in all, the oldest K950279 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
- 3 generations backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
- 2 generations backK971776 EchovacsVmi Technologies · 1997
- 1 generation backK990052 Tel-Echo SystemInnovative Medical Solutions, Inc. · 1999
- This deviceK032324 EchoencoderIcardiogram, Incorporated · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive… | Cemax-Icon, Inc. | 1996 | — |
| −3 | K963610 | Aki Compacs Data Compresion Module for Diagnostic Images | A.L.I. Technologies, Inc. | 1996 | — |
| −2 | K971776 | Echovacs | Vmi Technologies | 1997 | — |
| −1 | K990052 | Tel-Echo System | Innovative Medical Solutions, Inc. | 1999 | — |
| 0 (this device) | K032324 | Echoencoder | Icardiogram, Incorporated | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K990052 | Tel-Echo SystemSummary page 1…892.2050 Picture archiving and communications system Predicate substantially equivalent devices: K990052 Tel-Echo System K980060 EchoLINK Device description: Echo… | 1999 |
| * | K980060 | EcholinkSummary page 1…nications system Predicate substantially equivalent devices: K990052 Tel-Echo System K980060 EchoLINK Device description: Echoencoder is a combined software-hardware system that is composed of… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 7 ancestors has a recall.
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?
The device is intended to be used by health care professionals in the field of echocardiography. The device is capable of transferring ultrasound images over long distances as digital files. It is used to transmit echocardiograms over the Internet for the purpose of interpretation of echocardiograms at a remote location. It is anticipated that it will be used when echocardiograms must be performed in a location where no interpreting cardiologist is present, and will facilitate prompt interpretation of echocardiograms. It should be particularly useful in rural areas of the United States.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032324: Echoencoder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032324
Report an extraction error
Are you the manufacturer?
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