510(k) · Cleared
ClearedVscan with Dual Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Sysyems Ultrasound & Primary Care Diagn · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 16, 2014 as substantially equivalent to K092756 (Ge Vingmed Ultrasound AS, 2009) and 1 other predicate after a 58-day review. Its family tree reaches back 15 generations to 1995. 29 later devices descend from it.
- Decided
- May 16, 2014
- Review
- 58 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K935595 (1995). 126 ancestors in all, the oldest K863700 (1987). 29 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 2 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 1 generation backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- This deviceK140693 Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn · 2014
- Descendant · cites it directly · 25 of its ownK161588 Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · Recalled
- Descendant · 2 generations on · 10 of its ownK180995 Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · Recalled
- Descendant · 2 generations on · 9 of its ownK181727 Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018
- Descendant · 3 generations on · 3 of its ownK202035 Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- Descendant · 3 generations on · 3 of its ownK200708 Vivid iqGe Medical Systems Ultrasound And · 2020
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 6 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 5 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 3 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 2 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 1 generation backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- This deviceK140693 Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn · 2014
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2016 · cites it directly25descendants
- K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on10descendants
- K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 2 generations on9descendants
- K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020 · 3 generations on3descendants
- K200708Vivid iqGe Medical Systems Ultrasound And · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −6 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −2 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −1 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| 0 (this device) | K140693 | Vscan with Dual Probe | Ge Medical Sysyems Ultrasound & Primary Care Diagn | 2014 | — |
| +1 | K161588 | Vscan Extend | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2016 | 8 |
| +2 | K180995 | Vscan Extend | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | 7 |
| +2 | K181727 | Vivid iq | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | — |
| +3 | K202035 | Vscan Air | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| +3 | K200708 | Vivid iq | Ge Medical Systems Ultrasound And | 2020 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092756 | GE Vscan Compact Diagnostic Ultrasound SystemSummary page 1…90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570. 90-ITX Predicate Device(s): Vscan Diagnostic Ultrasound System - K092756 Vivid e Diagnostic Ultrasound System - KI 113690 Venue 40 Diagnos… | 2009 |
| * | K113690 | GE Logiq I, Logiq E and Vivid ESummary page 1…90-ITX Predicate Device(s): Vscan Diagnostic Ultrasound System - K092756 Vivid e Diagnostic Ultrasound System - KI 113690 Venue 40 Diagnostic Ultrasound System - KI 12122… | 2011 |
| Kept off the family tree | K121122 | FDA’s K121122 is Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid Control Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
What descends from it? (29)
See all 293 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 19 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 28 of the 126 ancestors have a recall of any class.
- Of its descendants, K161588 (GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, 2016) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K092756.
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. 2014, 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 with Dual Probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid…
Read the full statement (163 words)
Vscan with Dual Probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications:
Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid: Peripheral Vascular Imaging(e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels(e.g. central lines, upper extremity); Imaging Guidance for Needle/Catheter Placement(e.g. paracentesis. thoracentesis. amniocentesis); Thoracic/Lung(e.g. pleural motion/sliding, line artifacts): Thyroid and other Small Organs: Long Bone; Hip and Knee Joints; and Pediatrics
Its 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, triage assessments, and procedural guidance for adults and pediatrics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140693 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140693: Vscan with Dual Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140693
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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