510(k) · Cleared
Recalled · Class II · 2012Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System
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 Sep 1, 2011 as substantially equivalent to K101236 (GE Healthcare, 2011) after a 30-day review. Its family tree reaches back 5 generations to 2000. 404 later devices descend from it. It has been recalled once.
- Decided
- Sep 1, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003525 (2000). 404 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- 4 generations backK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
- 3 generations backK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · Recalled
- 2 generations backK061682 GE Voluson E8 Ultrasound SystemGeneral Electric Co. · 2006 · Recalled
- 1 generation backK101236 Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model…GE Healthcare · 2011
- This deviceK112213 Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011
- Descendant · cites it directly · 402 of its ownK113758 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
- Descendant · 2 generations on · 365 of its ownK122327 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
- Descendant · 3 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
Showing 5 of 404 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 404 · See all- K113758Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · cites it directly402descendants
- K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 2 generations on365descendants
- K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · 3 generations on323descendants
- K120741Voluson S6, Voluson S8GE Healthcare · 2012 · cites it directly295descendants
- K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013 · 2 generations on270descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003525 | Voluson 730 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| −4 | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound System | General Electric Co. | 2003 | — |
| −3 | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04 | General Electric Co. | 2004 | 1 |
| −2 | K061682 | GE Voluson E8 Ultrasound System | General Electric Co. | 2006 | 3 |
| −1 | K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/… | GE Healthcare | 2011 | — |
| 0 (this device) | K112213 | Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System | GE Healthcare | 2011 | — |
| +1 | K113758 | Voluson E6/E8/E8EXPERT/E10 | GE Healthcare | 2012 | — |
| +2 | K122327 | Voluson E6/E8/E8EXPERT/E10 | GE Healthcare | 2012 | — |
| +3 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 8 | 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 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? (2)
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 |
|---|---|---|---|
| * | K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BMSummary page 1…Pulsed Echo Imaging System, 2lICFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K101236 Voluson E6IE8IESExpert Diagnostic Ultrasound System K1 1149 Vivid E9… | 2011 |
| Kept off the family tree | K111149 | FDA’s K111149 is Hanarostent Biliary (NNN) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
What descends from it? (404)
See all 4043 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 |
|---|---|---|---|---|
| Jul 13, 2012 | Class II | Z-1833-2013 | Software design | GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K113758 (GE Healthcare, 2012) has gone furthest, with 402 descendants of its own.
- 7 other devices also cite its predicate K101236.
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. 2011, 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 remain the same as previously cleared: Fetab1 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/K112213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112213: Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112213
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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