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 and Primary Care Diagnostics · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 25, 2018 as substantially equivalent to K161588 (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2016) and 2 other predicates after a 70-day review. Its family tree reaches back 20 generations to 1995. 10 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 25, 2018
- Review
- 70 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 20 generations to K935595 (1995). 156 ancestors in all, the oldest K863700 (1987). 10 later devices descend from it, 3 citing it directly.
- Root · 20 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations between
- 3 generations backK133034 Logiq F SeriesGE Healthcare · 2014
- 2 generations backK141768 Logiq V5/Logiq V3GE Healthcare · 2014
- 1 generation backK161224 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016
- This deviceK180995 Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · cites it directly · 3 of its ownK202035 Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- Descendant · cites it directly · 3 of its ownK181934 Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK200851 Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- Descendant · 2 generations on · 1 of its ownK231301 Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2023
- Descendant · 3 generations on · 1 of its ownK221147 Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
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 backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 4 generations backK122387 Voluson P6, Voluson P8GE Healthcare · 2012
- 3 generations backK133034 Logiq F SeriesGE Healthcare · 2014
- 2 generations backK141768 Logiq V5/Logiq V3GE Healthcare · 2014
- 1 generation backK161224 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016
- This deviceK180995 Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · cites it directly3descendants
- K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2018 · cites it directly3descendants
- K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · 2 generations on2descendants
- K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2023 · 2 generations on1descendant
- K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · 3 generations on1descendant
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 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −4 | K122387 | Voluson P6, Voluson P8 | GE Healthcare | 2012 | — |
| −3 | K133034 | Logiq F Series | GE Healthcare | 2014 | — |
| −2 | K141768 | Logiq V5/Logiq V3 | GE Healthcare | 2014 | — |
| −1 | K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | — |
| 0 (this device) | K180995 | Vscan Extend | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +1 | K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| +1 | K181934 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2018 | — |
| +2 | K200851 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| +2 | K231301 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2023 | — |
| +3 | K221147 | Vivid T8, Vivid T9 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | — |
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 | 13 | 0 |
| 2005 | 12 | 0 |
| 2006 | 9 | 0 |
| 2007 | 7 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K161588 | Vscan ExtendSummary page 4…y) Intraoperative Neurological Laparoscopic Interventional Guidance Vascular Access [l P P P Nonvascular P P =] =) N = new indication; P = previously cleared by FDA (K161588) Notes: [1]1 Abdominal includes Gynecology, Renal and Urology; [2] Small Organ includes, thyroid; [3] Peripheral Vascular inc… | 2016 |
| * | K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3Summary page 7…sed Echo Imaging System, 21CFR 892.1560, 90-1YO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-1TX Vscan Extend - K161588 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 — K161224 LVivo EF System from DiACardio Ltd. — K130779 Vscan Extend is a pocket-sized, battery powered general purpose, track 3, diagnost… | 2016 |
| * | K130779 | Lvivo EF SystemSummary page 7…O; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-1TX Vscan Extend - K161588 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 — K161224 LVivo EF System from DiACardio Ltd. — K130779 Vscan Extend is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system. The system consists of a… | 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)
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. |
The 5 latest of 7 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 23 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 38 of the 156 ancestors have a recall of any class.
- Of its descendants, K202035 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K161588.
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. 2018, 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 (201 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/K180995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180995: 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/K180995
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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