510(k) · Cleared
ClearedVentripoint Medical System Plus (VMS+) 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventripoint Diagnostics, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Oct 16, 2019 as substantially equivalent to K150085 (Ge Vingmed Ultrasound AS, 2015) after a 133-day review. Its family tree reaches back 20 generations to 1995. 1 later device descends from it.
- Decided
- Oct 16, 2019
- Review
- 133 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K935595 (1995). 139 ancestors in all, the oldest K863700 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations between
- 3 generations backK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
- 2 generations backK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
- 1 generation backK150085 GE EchoPACGe Vingmed Ultrasound AS · 2015
- This deviceK191493 Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK241222 Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd. · 2025
Show all 20 generations
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 19 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 18 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 17 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 16 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 15 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 14 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 11 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 10 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 9 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 8 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 7 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 6 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 5 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 4 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- 3 generations backK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
- 2 generations backK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
- 1 generation backK150085 GE EchoPACGe Vingmed Ultrasound AS · 2015
- This deviceK191493 Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −19 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −18 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −17 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −16 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −15 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −14 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −11 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −10 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −9 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −8 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −7 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −6 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −5 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −4 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| −3 | K141093 | 6VT-D Ultrasound Transducer | Ge Vingmed Ultrasound AS | 2014 | — |
| −2 | K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | Ge Medical Systems Israel, Ltd. | 2014 | 3 |
| −1 | K150085 | GE EchoPAC | Ge Vingmed Ultrasound AS | 2015 | — |
| 0 (this device) | K191493 | Ventripoint Medical System Plus (VMS+) 3.0 | Ventripoint Diagnostics, Ltd. | 2019 | — |
| +1 | K241222 | Ventripoint Medical System Plus (VMS+) 4.0 | Ventripoint Diagnostics, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 12 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K150085 | GE EchoPACSummary page 4…Diagnostic ultrasonic transducer 892.1570 90 ITX A. LEGALLY MARKETED PREDICATE DEVICE Device Name GE EchoPAC 510(k) Number K150085 Common Name: Picture Archiving and Communications System Classification: Regulatory Class: II… | 2015 |
| † | K173810 | Ventripoint Medical System Plus (VMS+) | 2018 |
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 |
|---|---|---|---|
| K241222 | Ventripoint Medical System Plus (VMS+) 4.0 | 2025 | 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 24 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 45 of the 139 ancestors have a recall of any class.
- Of its descendants, K241222 (Ventripoint Diagnostics, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K150085.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 VMS+ 3.0 is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.
The VMS+ 3.0 is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191493: Ventripoint Medical System Plus (VMS+) 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191493
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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