510(k) · Cleared
ClearedEchoMD Automated Ejection Fraction Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bay Labs, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jun 14, 2018 as substantially equivalent to K130779 (Diacardio, Ltd., 2013) after a 184-day review. Its family tree reaches back 12 generations to 1995. 10 later devices descend from it.
- Decided
- Jun 14, 2018
- Review
- 184 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K935595 (1995). 50 ancestors in all, the oldest K921148 (1992). 10 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 1 generation backK130779 Lvivo EF SystemDiacardio, Ltd. · 2013
- This deviceK173780 EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK210791 Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai · 2021
- Descendant · cites it directly · 3 of its ownK200621 Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK210747 Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2022
- Descendant · cites it directly · 1 of its ownK220956 Libby Echo:PrioDyad Medical, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK253593 Clarius Ejection Fraction AIClarius Mobile Health Corp. · 2026
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 4 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 1 generation backK130779 Lvivo EF SystemDiacardio, Ltd. · 2013
- This deviceK173780 EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai · 2021 · cites it directly3descendants
- K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2020 · cites it directly3descendants
- K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2022 · 2 generations on2descendants
- K220956Libby Echo:PrioDyad Medical, Inc. · 2022 · cites it directly1descendant
- K253593Clarius Ejection Fraction AIClarius Mobile Health Corp. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −6 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −4 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −3 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −2 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −1 | K130779 | Lvivo EF System | Diacardio, Ltd. | 2013 | — |
| 0 (this device) | K173780 | EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | 2018 | — |
| +1 | K210791 | Us2.v1 | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2021 | — |
| +1 | K200621 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | 2020 | 1 |
| +2 | K210747 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | 2022 | — |
| +1 | K220956 | Libby Echo:Prio | Dyad Medical, Inc. | 2022 | — |
| +3 | K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 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? (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 |
|---|---|---|---|
| * | K130779 | Lvivo EF SystemSummary page 4…R § 892.2050 Regulatory Class: II Product Code: LLZ, System, Image processing, Radiological Predicate Device Diacardio, Ltd. LVivo EF Software (K130779) Intended Use / Indications for Use The Bay Labs, Inc. EchoMD Automated Ejection Fraction software is used to process pr… | 2013 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 12 of the 50 ancestors have a recall of any class.
- Of its descendants, K210791 (Eko.Ai Pte Ltd. D/B/A Us2.Ai, 2021) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K130779.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Bay Labs, Inc. EchoMD Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.
The EchoMD Automated Ejection Fraction Software is indicated for use in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173780 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173780: EchoMD Automated Ejection Fraction Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173780
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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