510(k) · Cleared
Recalled · 2009GE Voluson E8 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jul 12, 2006 as substantially equivalent to K003525 (Medison America, Inc., 2000) and 2 other predicates after a 27-day review. Its family tree reaches back 3 generations to 2000. 554 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 12, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003525 (2000). 554 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
- 2 generations backK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
- 1 generation backK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004 · Recalled
- This deviceK061682 GE Voluson E8 Ultrasound SystemGeneral Electric Co. · 2006
- Descendant · cites it directly · 445 of its ownK101236 Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model…GE Healthcare · 2011
- Descendant · 2 generations on · 404 of its ownK112213 Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011 · Recalled
- Descendant · 3 generations on · 402 of its ownK113758 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
- Descendant · 4 generations on · 365 of its ownK122327 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012
- Descendant · 5 generations on · 323 of its ownK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
Showing 5 of 554 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 554 · See all- K101236Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BMGE Healthcare · 2011 · cites it directly445descendants
- K112213Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011 · 2 generations on404descendants
- K113758Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 3 generations on402descendants
- K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 4 generations on365descendants
- K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · 5 generations on323descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003525 | Voluson 730 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | — |
| −2 | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound System | General Electric Co. | 2003 | — |
| −1 | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04 | General Electric Co. | 2004 | 1 |
| 0 (this device) | K061682 | GE Voluson E8 Ultrasound System | General Electric Co. | 2006 | — |
| +1 | K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/… | GE Healthcare | 2011 | — |
| +2 | K112213 | Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System | GE Healthcare | 2011 | 1 |
| +3 | K113758 | Voluson E6/E8/E8EXPERT/E10 | GE Healthcare | 2012 | — |
| +4 | K122327 | Voluson E6/E8/E8EXPERT/E10 | GE Healthcare | 2012 | — |
| +5 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 13 | 0 |
| 2012 | 24 | 0 |
| 2013 | 17 | 0 |
| 2014 | 31 | 0 |
| 2015 | 28 | 0 |
| 2016 | 36 | 0 |
| 2017 | 40 | 0 |
| 2018 | 48 | 0 |
| 2019 | 32 | 0 |
| 2020 | 46 | 0 |
| 2021 | 33 | 0 |
| 2022 | 38 | 0 |
| 2023 | 36 | 0 |
| 2024 | 42 | 0 |
| 2025 | 45 | 0 |
| 2026 | 33 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003525 | Voluson 730 Diagnostic Ultrasound SystemSummary page 1…892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Voluson 730 Diagnostic Ultrasound System - K003525, K032620, K041 688 A device currently in commercial distribution. 4. Device Description: The Voluson ES… | 2000 |
| * | K032620 | GE Voluson 730 Pro/Expert BT03 Ultrasound SystemSummary page 1…, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Voluson 730 Diagnostic Ultrasound System - K003525, K032620, K041 688 A device currently in commercial distribution. 4. Device Description: The Voluson ES is a ful… | 2003 |
| * | K041688 | GE Voluson 730 Pro/Expert Untrasound BT04Summary page 1…Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Voluson 730 Diagnostic Ultrasound System - K003525, K032620, K041 688 A device currently in commercial distribution. 4. Device Description: The Voluson ES is a full featured… | 2004 |
What descends from it? (554)
See all 5547 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101236 | Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM | 2011 | 445 |
| K103649 | Voluson S6, Voluson S8 | 2011 | 296 |
| K103677 | M7/M7T Diagnostic Ultrasound System | 2011 | 123 |
| K103583 | DC-7 Diagnostic Ultrasound System | 2010 | 123 |
| K081065 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 | 2008 | 118 |
| K091009 | MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60… | 2009 | 51 |
| K101166 | 4D-View 9.1 (4D View PC Software) Model: H48651SZ | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2009 | Not classified | Z-0541-2010 | Software design | GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8 Diagnostic Ultrasound Systems that may impact patient safety. When using… |
| Apr 1, 2008 | Not classified | Z-2404-2008 | Software design | Inaccurate dimension measurements in M-Mode when pan-Zoom is activated in GE Voluson E8 Ultrasound Systems. Of particular concern are potential inaccuracies of fetal cardiac measurements that may impact patient safety. |
| Jul 6, 2007 | Not classified | Z-0113-2008 | Software design | When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K101236 (GE Healthcare, 2011) has gone furthest, with 445 descendants of its own.
- 9 other devices also cite its predicate K003525.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061682: GE Voluson E8 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/K061682
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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