510(k) · Cleared
ClearedVoluson E6/E8/E8EXPERT/E10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · IYE Accelerator, Linear, Medical
Cleared on Jan 10, 2012 as substantially equivalent to K112213 (GE Healthcare, 2011) after a 20-day review. Its family tree reaches back 6 generations to 2000. 402 later devices descend from it.
- Decided
- Jan 10, 2012
- Review
- 20 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003525 (2000). 402 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- 5 generations backK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
- 4 generations backK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · Recalled
- 3 generations backK061682 GE Voluson E8 Ultrasound SystemGeneral Electric Co. · 2006 · Recalled
- 2 generations backK101236 Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model…GE Healthcare · 2011
- 1 generation backK112213 Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011 · Recalled
- This deviceK113758 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
- Descendant · cites it directly · 365 of its ownK122327 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
- Descendant · 2 generations on · 323 of its ownK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- Descendant · cites it directly · 295 of its ownK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- Descendant · 2 generations on · 270 of its ownK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- Descendant · 3 generations on · 263 of its ownK142160 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · Recalled
Showing 5 of 402 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 402 · See all- K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · cites it directly365descendants
- K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · 2 generations on323descendants
- K120741Voluson S6, Voluson S8GE Healthcare · 2012 · cites it directly295descendants
- K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013 · 2 generations on270descendants
- K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2014 · 3 generations on263descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003525 | Voluson 730 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| −5 | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound System | General Electric Co. | 2003 | — |
| −4 | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04 | General Electric Co. | 2004 | 1 |
| −3 | K061682 | GE Voluson E8 Ultrasound System | General Electric Co. | 2006 | 3 |
| −2 | K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/… | GE Healthcare | 2011 | — |
| −1 | K112213 | Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System | GE Healthcare | 2011 | 1 |
| 0 (this device) | K113758 | Voluson E6/E8/E8EXPERT/E10 | GE Healthcare | 2012 | — |
| +1 | K122327 | Voluson E6/E8/E8EXPERT/E10 | GE Healthcare | 2012 | — |
| +2 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| +1 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| +2 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| +3 | K142160 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 14 | 0 |
| 2015 | 20 | 0 |
| 2016 | 25 | 0 |
| 2017 | 32 | 0 |
| 2018 | 35 | 0 |
| 2019 | 27 | 0 |
| 2020 | 38 | 0 |
| 2021 | 31 | 0 |
| 2022 | 34 | 0 |
| 2023 | 27 | 0 |
| 2024 | 37 | 0 |
| 2025 | 41 | 0 |
| 2026 | 28 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K112213 | Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System | 2011 |
What descends from it? (402)
See all 4025 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 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K122327 (GE Healthcare, 2012) has gone furthest, with 365 descendants of its own.
- 2 other devices also cite its predicate K112213.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113758 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113758: Voluson E6/E8/E8EXPERT/E10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113758
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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