510(k) · Cleared
Recalled · Class II · 2021Vscan Extend
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 31, 2016 as substantially equivalent to K140693 (Ge Medical Sysyems Ultrasound & Primary Care Diagn, 2014) after an 84-day review. Its family tree reaches back 16 generations to 1995. 25 later devices descend from it. It has been recalled 8 times.
- Decided
- Aug 31, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 16 generations to K935595 (1995). 127 ancestors in all, the oldest K863700 (1987). 25 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations between
- 3 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 2 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 1 generation backK140693 Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn · 2014
- This deviceK161588 Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016
- Descendant · cites it directly · 10 of its ownK180995 Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · Recalled
- Descendant · cites it directly · 9 of its ownK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · 2 generations on · 3 of its ownK202035 Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- Descendant · 2 generations on · 3 of its ownK200708 Vivid iqGe Medical Systems Ultrasound And · 2020
- Descendant · 2 generations on · 3 of its ownK191792 Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019
Show all 16 generations
- Root · 16 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 14 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 13 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 12 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 9 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 7 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 6 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 4 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 3 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 2 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 1 generation backK140693 Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn · 2014
- This deviceK161588 Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · cites it directly10descendants
- K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · cites it directly9descendants
- K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · 2 generations on3descendants
- K200708Vivid iqGe Medical Systems Ultrasound And · 2020 · 2 generations on3descendants
- K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −15 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −14 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −13 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −12 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −10 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −9 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −7 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −6 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −4 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −2 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −1 | K140693 | Vscan with Dual Probe | Ge Medical Sysyems Ultrasound & Primary Care Diagn | 2014 | — |
| 0 (this device) | K161588 | Vscan Extend | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | — |
| +1 | K180995 | Vscan Extend | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | 7 |
| +1 | K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +2 | K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| +2 | K200708 | Vivid iq | Ge Medical Systems Ultrasound And | 2020 | — |
| +2 | K191792 | Versana Balance | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 6 | 0 |
| 1996 | 3 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 9 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 11 | 0 |
| 2005 | 11 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K140693 | Vscan with Dual ProbeSummary page 5…7 Nonvascular N N N N 7 N = new indication; P= previously cleared by FDA in K140693 Notes: [1] Abdominal includes Gynecology, Renal and Urology; [2] Small Organ includes thyroid; [3] Periph… | 2014 |
| † | K152758 | Venue 50 | 2015 |
| † | K112122 | VENUE 40 | 2011 |
What descends from it? (25)
See all 253 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2021 | Class II | Z-0520-2022 | Device Design | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power. |
| Nov 4, 2021 | Class II | Z-0523-2022 | Device Design | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power. |
| Nov 4, 2021 | Class II | Z-0518-2022 | Device Design | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power. |
| Nov 4, 2021 | Class II | Z-0522-2022 | Device Design | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power. |
| Nov 4, 2021 | Class II | Z-0519-2022 | Device Design | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power. |
| Nov 4, 2021 | Class II | Z-0524-2022 | Device Design | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power. |
| Nov 4, 2021 | Class II | Z-0521-2022 | Device Design | The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power. |
| May 21, 2019 | Class II | Z-1839-2019 | Software design | Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 28 of the 127 ancestors have a recall of any class.
- Of its descendants, K180995 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2018) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K140693.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Vscan Extend is a general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and…
Read the full statement (202 words)
Vscan Extend is a general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine. periodic monitoring. and triage.
With the phased array transducer on the sector probe, the specific clinical applications and exam types include: Cardiac: Abdominal: Renal: OB/GYN: Urology: Fetal. Evaluation of Presence of Fluid: Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis. thoracentesis. amniocentesis): Peripheral Vascular Imaging (e.g. arteries and veins): Thoracic/Lung (e.g. pleural motion/sliding. line artifacts): Adult Cephalic: and Pediatrics.
With the addition of the linear array transducer on the single dual headed probe solution. the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity. carotid): Procedure Guidance for Arterial or Venous Vessels (e.g. central lines. upper extremity): Small Organs (e.g. thyroid): and Musculoskeletal (Long Bone: Hip. shoulder. elbow and Knee Joints): Evaluation of Presence of Fluid: Thoracic/Lung (e.g. pleural motion/sliding. line artifacts): and Pediatrics.
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/K161588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161588: Vscan Extend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161588
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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