510(k) · Cleared
ClearedGE Echopac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Vingmed Ultrasound AS · LLZ System, Image Processing, Radiological
Cleared on Jan 29, 2013 as substantially equivalent to K120221 (GE Healthcare, 2012) and 1 other predicate after a 42-day review. Its family tree reaches back 8 generations to 2001. 9 later devices descend from it.
- Decided
- Jan 29, 2013
- Review
- 42 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K003931 (2001). 16 ancestors in all, the oldest K000695 (2000). 9 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
- 7 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
- 6 generations backK041552 GE Vivid 7 BT04General Electric Co. · 2004
- 5 generations backK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
- 4 generations backK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · Recalled
- 3 generations backK072952 GE EchopacGeneral Electric Co. · 2007
- 2 generations backK101324 GE Echopac Model BT10Ge Vingmed Ultrasound AS · 2010
- 1 generation backK120221 GE EchopacGE Healthcare · 2012
- This deviceK123894 GE EchopacGe Vingmed Ultrasound AS · 2013
- Descendant · cites it directly · 8 of its ownK131685 GE EchopacGe Vingmed Ultrasound AS · 2013
- Descendant · 2 generations on · 7 of its ownK150085 GE EchoPACGe Vingmed Ultrasound AS · 2015
- Descendant · 3 generations on · 4 of its ownK170847 EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2017
- Descendant · 4 generations on · 3 of its ownK200852 EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- Descendant · 5 generations on · 2 of its ownK220940 EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131685GE EchopacGe Vingmed Ultrasound AS · 2013 · cites it directly8descendants
- K150085GE EchoPACGe Vingmed Ultrasound AS · 2015 · 2 generations on7descendants
- K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · 3 generations on4descendants
- K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · 4 generations on3descendants
- K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003931 | Vivid 7 with Sonopac, Model FB0008XX | Ge Medical Systems, Inc. | 2001 | — |
| −7 | K031663 | GE Vivid 7, Model FC0003XX | General Electric Co. | 2003 | — |
| −6 | K041552 | GE Vivid 7 BT04 | General Electric Co. | 2004 | — |
| −5 | K051449 | GE Vivid 7 with or Without Suffix | GE Medical Systems | 2005 | — |
| −4 | K060542 | GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX | General Electric Co. | 2006 | 1 |
| −3 | K072952 | GE Echopac | General Electric Co. | 2007 | — |
| −2 | K101324 | GE Echopac Model BT10 | Ge Vingmed Ultrasound AS | 2010 | — |
| −1 | K120221 | GE Echopac | GE Healthcare | 2012 | — |
| 0 (this device) | K123894 | GE Echopac | Ge Vingmed Ultrasound AS | 2013 | — |
| +1 | K131685 | GE Echopac | Ge Vingmed Ultrasound AS | 2013 | — |
| +2 | K150085 | GE EchoPAC | Ge Vingmed Ultrasound AS | 2015 | — |
| +3 | K170847 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2017 | — |
| +4 | K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| +5 | K220940 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K120221 | GE EchopacSummary page 1…reporting Classification Names: 21 CIFR 892.2050< Product Code:LL Predicate Device(s): K120221 - GE EchoPAC K121063 - GE Vivid S5/S6 Diagnostic Ultrasound System - includ… | 2012 |
| * | K121063 | Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemSummary page 1…: 21 CIFR 892.2050< Product Code:LL Predicate Device(s): K120221 - GE EchoPAC K121063 - GE Vivid S5/S6 Diagnostic Ultrasound System - including EchoPilot Software Device Descriotion:… | 2012 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131685 | GE Echopac | 2013 | 8 |
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 12 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K131685 (Ge Vingmed Ultrasound AS, 2013) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K120221.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & OW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular…
Read the full statement (141 words)
The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & OW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123894: GE Echopac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123894
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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