# K053435: GE Voluson I

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Dec 16, 2005 after 7 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- 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.
407 later devices descend from it; 6 cite it directly.
0 of 411 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.
- (no number) GE LOGIQe: named in the summary without a submission number

## Most influential descendants
- K103649: Voluson S6, Voluson S8 (2011), 296 descendants of its own
- K120741: Voluson S6, Voluson S8 (2012), 295 descendants of its own
- K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 (2013), 270 descendants of its own
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 (2013), 255 descendants of its own
- K122387: Voluson P6, Voluson P8 (2012), 201 descendants of its own

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

Source page: https://510kreport.com/device/K053435
Methodology: https://510kreport.com/methodology