# K061682: GE Voluson E8 Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Jul 12, 2006 after 27 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003525 (2000). 3 ancestors in all.
554 later devices descend from it; 7 cite it directly.
0 of 558 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003525: Voluson 730 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.
- K032620: GE Voluson 730 Pro/Expert BT03 Ultrasound System, General Electric Co. (2003) Summary page 1.
- K041688: GE Voluson 730 Pro/Expert Untrasound BT04, General Electric Co. (2004) Summary page 1.

## Most influential descendants
- K101236: Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM (2011), 445 descendants of its own
- K112213: Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System (2011), 404 descendants of its own
- K113758: Voluson E6/E8/E8EXPERT/E10 (2012), 402 descendants of its own
- K122327: Voluson E6/E8/E8EXPERT/E10 (2012), 365 descendants of its own
- K123564: Logiq E9 Diagnostic Ultrasound System (2012), 323 descendants of its own

## Recalls of this device
- Oct 22, 2009 · Not classified · Z-0541-2010: 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
- Apr 1, 2008 · Not classified · Z-2404-2008: 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 impa
- Jul 6, 2007 · Not classified · Z-0113-2008: 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 re

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K061682
Methodology: https://510kreport.com/methodology