510(k) · Cleared
ClearedVoluson S6, Voluson S8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 18, 2014 as substantially equivalent to K120741 (GE Healthcare, 2012) and 3 other predicates after a 29-day review. Its family tree reaches back 18 generations to 1995. 151 later devices descend from it.
- Decided
- Jul 18, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 18 generations to K935595 (1995). 128 ancestors in all, the oldest K863700 (1987). 151 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 2 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 1 generation backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- This deviceK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- Descendant · cites it directly · 131 of its ownK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- Descendant · 2 generations on · 107 of its ownK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- Descendant · 3 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 2 generations on · 57 of its ownK152195 Logiq S8GE Healthcare · 2015
- Descendant · cites it directly · 55 of its ownK160184 Voluson S6, Voluson S8, Voluson S10GE Healthcare · 2016 · Recalled
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 9 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 8 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 6 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 5 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 4 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 3 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 2 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 1 generation backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- This deviceK141639 Voluson S6, Voluson S8GE Healthcare · 2014
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 151 · See all- K143452Logiq P9, Logiq P7GE Healthcare · 2015 · cites it directly131descendants
- K161047LOGIQ P9 and LOGIQ P7GE Healthcare · 2016 · 2 generations on107descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 3 generations on58descendants
- K152195Logiq S8GE Healthcare · 2015 · 2 generations on57descendants
- K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare · 2016 · cites it directly55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −8 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −6 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −5 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −3 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −2 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −1 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| 0 (this device) | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| +1 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| +2 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| +3 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +2 | K152195 | Logiq S8 | GE Healthcare | 2015 | — |
| +1 | K160184 | Voluson S6, Voluson S8, Voluson S10 | GE Healthcare | 2016 | 1 |
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 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2018 | 15 | 0 |
| 2019 | 16 | 0 |
| 2020 | 20 | 0 |
| 2021 | 14 | 0 |
| 2022 | 22 | 0 |
| 2023 | 11 | 0 |
| 2024 | 15 | 0 |
| 2025 | 11 | 0 |
| 2026 | 10 | 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? (4)
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 |
|---|---|---|---|
| * | K120741 | Voluson S6, Voluson S8Summary page 1…Pulsed Echo Imaging System. 2ICER 892.1560, 90-IYO Diagnostic Ultrasound Transducer. 21I CER 892.1570. 90-ITX Predicate Device(s): K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System K132913 Voluson E Series… | 2012 |
| * | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10Summary page 1…c Ultrasound Transducer. 21I CER 892.1570. 90-ITX Predicate Device(s): K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System K132913 Voluson E Series K 122387 Voluson P6/P8 K 121063 Vivid S5/S6 D… | 2013 |
| * | K122387 | Voluson P6, Voluson P8Summary page 1…Predicate Device(s): K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System K132913 Voluson E Series K 122387 Voluson P6/P8 K 121063 Vivid S5/S6 Device Description: The subject device consists of a m… | 2012 |
| * | K121063 | Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemSummary page 1…S8 Diagnostic Ultrasound System K132913 Voluson E Series K 122387 Voluson P6/P8 K 121063 Vivid S5/S6 Device Description: The subject device consists of a mobile console with keyboard.… | 2012 |
What descends from it? (151)
See all 1513 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 5 companies; a new generation was cleared every 11 months on median.
- 36 of the 128 ancestors have a recall of any class.
- Of its descendants, K143452 (GE Healthcare, 2015) has gone furthest, with 131 descendants of its own.
- 4 other devices also cite its predicate K120741.
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?
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic: Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
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/K141639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141639: Voluson S6, Voluson S8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141639
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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