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 Apr 27, 2012 as substantially equivalent to K103649 (GE Healthcare, 2011) and 4 other predicates after a 46-day review. Its family tree reaches back 15 generations to 1995. 295 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 46 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K935595 (1995). 115 ancestors in all, the oldest K863700 (1987). 295 later devices descend from it, 5 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 deviceK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- Descendant · cites it directly · 270 of its ownK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- Descendant · 2 generations on · 255 of its ownK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- Descendant · cites it directly · 201 of its ownK122387 Voluson P6, Voluson P8GE Healthcare · 2012
- Descendant · 3 generations on · 187 of its ownK142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare · 2015
- Descendant · 2 generations on · 155 of its ownK133034 Logiq F SeriesGE Healthcare · 2014
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 deviceK120741 Voluson S6, Voluson S8GE Healthcare · 2012
Showing 5 of 295 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 295 · See all- K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013 · cites it directly270descendants
- K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013 · 2 generations on255descendants
- K122387Voluson P6, Voluson P8GE Healthcare · 2012 · cites it directly201descendants
- K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare · 2015 · 3 generations on187descendants
- K133034Logiq F SeriesGE Healthcare · 2014 · 2 generations on155descendants
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) | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| +1 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| +2 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| +1 | K122387 | Voluson P6, Voluson P8 | GE Healthcare | 2012 | — |
| +3 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | GE Healthcare | 2015 | — |
| +2 | K133034 | Logiq F Series | GE Healthcare | 2014 | — |
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 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 12 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 10 | 0 |
| 2016 | 16 | 0 |
| 2017 | 23 | 0 |
| 2018 | 30 | 0 |
| 2019 | 26 | 0 |
| 2020 | 30 | 0 |
| 2021 | 25 | 0 |
| 2022 | 31 | 0 |
| 2023 | 21 | 0 |
| 2024 | 29 | 0 |
| 2025 | 29 | 0 |
| 2026 | 15 | 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? (5)
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 |
|---|---|---|---|
| * | K103649 | Voluson S6, Voluson S8Summary page 1…ltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K103649 Voluson S6, Voluson S8 Diagnostic Ultrasound System KL 13758, Ki 12213 Voluson E6ESE8ExpertElO… | 2011 |
| * | K113758 | Voluson E6/E8/E8EXPERT/E10 | 2012 |
| * | K112213 | Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System | 2011 |
| * | K053435 | GE Voluson ISummary page 1…Device(s): K103649 Voluson S6, Voluson S8 Diagnostic Ultrasound System KL 13758, Ki 12213 Voluson E6ESE8ExpertElO K053435 Voluson i K1 13690 LOGIQ e Device Description: The subject device consists of a mobile console… | 2005 |
| * | K113690 | GE Logiq I, Logiq E and Vivid ESummary page 1…nostic Ultrasound System KL 13758, Ki 12213 Voluson E6ESE8ExpertElO K053435 Voluson i K1 13690 LOGIQ e Device Description: The subject device consists of a mobile console with keyboard, spe… | 2011 |
What descends from it? (295)
See all 2955 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 17 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 31 of the 115 ancestors have a recall of any class.
- Of its descendants, K131267 (GE Healthcare, 2013) has gone furthest, with 270 descendants of its own.
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. 2012, 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 as stated in the FDA summary.
https://510kreport.com/device/K120741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120741: Voluson S6, Voluson S8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120741
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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