510(k) · Cleared
ClearedEchonet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lockheed Martin Communications Systems · LLZ System, Image Processing, Radiological
Cleared on May 7, 1996 after a 60-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- May 7, 1996
- Review
- 60 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK960946 EchonetLockheed Martin Communications Systems · 1996
- Descendant · cites it directly · 0 of its ownK980243 Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet…Parameter Developments, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K980243Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis)Parameter Developments, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960946 | Echonet | Lockheed Martin Communications Systems | 1996 | — |
| +1 | K980243 | Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis) | Parameter Developments, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K980243 | Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis) | 1998 | 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?
- Of its descendants, K980243 (Parameter Developments, Inc., 1998) has gone furthest, with 0 descendants of its own.
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?
EchoNet is software which runs on Unix workstations. EchoNet is intended to be used for storing and displaying digital images acquired by digital ultrasound imaging systems. EchoNet provides rapid network access to the imagery and patient demographic data stored on a central server. The system retrieves and stores images as unaltered computer data and as JPEG (Joint Photographic Experts Group) lossy compressed cine-loops. This dual-path storage system…
Read the full statement (115 words)
EchoNet is software which runs on Unix workstations. EchoNet is intended to be used for storing and displaying digital images acquired by digital ultrasound imaging systems. EchoNet provides rapid network access to the imagery and patient demographic data stored on a central server. The system retrieves and stores images as unaltered computer data and as JPEG (Joint Photographic Experts Group) lossy compressed cine-loops. This dual-path storage system allows for rapid access to high quality compressed images with the original unaltered (losslessly compressed) images available on demand. EchoNet is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).
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/K960946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960946: Echonet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960946
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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