510(k) · Cleared
ClearedTel-Echo System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Medical Solutions, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 19, 1999 as substantially equivalent to K964803 (Network Concepts, Inc., 1997) and 2 other predicates after a 43-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Feb 19, 1999
- Review
- 43 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K955092 (1996). 6 ancestors in all, the oldest K950279 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
- 2 generations backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
- 1 generation backK971776 EchovacsVmi Technologies · 1997
- This deviceK990052 Tel-Echo SystemInnovative Medical Solutions, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK032324 EchoencoderIcardiogram, Incorporated · 2003
Most influential descendants
Showing 1 of 1 · See all- K032324EchoencoderIcardiogram, Incorporated · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive… | Cemax-Icon, Inc. | 1996 | — |
| −2 | K963610 | Aki Compacs Data Compresion Module for Diagnostic Images | A.L.I. Technologies, Inc. | 1996 | — |
| −1 | K971776 | Echovacs | Vmi Technologies | 1997 | — |
| 0 (this device) | K990052 | Tel-Echo System | Innovative Medical Solutions, Inc. | 1999 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 1…m, which is for communication only. Comparisons to Predicate Device The substantial equivalent devices are: the Network Concepts, Inc. Univision System, FDA 510K Number K964803; VMI Technologies EchoVacs product, FDA 510K Number K971776; and the MPACS EchoLink product, FDA 510K Number K980060. 9-1 === P… | 1997 |
| * | K971776 | EchovacsSummary page 1…e Device The substantial equivalent devices are: the Network Concepts, Inc. Univision System, FDA 510K Number K964803; VMI Technologies EchoVacs product, FDA 510K Number K971776; and the MPACS EchoLink product, FDA 510K Number K980060. 9-1 INNOVATIVE MEDICAL SOLUTIONS In reviewing the com… | 1997 |
| * | K980060 | EcholinkSummary page 1…ork Concepts, Inc. Univision System, FDA 510K Number K964803; VMI Technologies EchoVacs product, FDA 510K Number K971776; and the MPACS EchoLink product, FDA 510K Number K980060. 9-1 INNOVATIVE MEDICAL SOLUTIONS In reviewing the comparison between Innovative Medical’s Tel-Echo system and… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032324 | Echoencoder | 2003 | 0 |
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 4 companies; a new generation was cleared every 8 months on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K032324 (Icardiogram, Incorporated, 2003) has gone furthest, with 0 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?
The Tel-Echo System is intended to acquire echocardiographic images during a cardiac ultrasound exam and transfer them to another location for viewing. This system is intended for tele-echocardiography applications.
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/K990052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990052: Tel-Echo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990052
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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