# K042833: Sonoline G20 Diagnostic Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 27, 2004 after 14 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933202 (1994). 8 ancestors in all.
928 later devices descend from it; 2 cite it directly.
2 of 937 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040502: Sonoline Ebisu Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.
- K020353: Omnia X/XS Ultrasound System, Siemens Medical Systems, Inc. (2002) Summary page 2.
- K946179: Siemens Sonoline 4XX, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.

## Most influential descendants
- K052894: Sonoline G60 S Ultrasound System (2005), 926 descendants of its own
- K063138: Modification to Acuson Antares Ultrasound System (2006), 802 descendants of its own
- K063803: Acuson Antares Diagnostic Ultrasound System (2007), 801 descendants of its own
- K072786: Acuson S2000 Ultrasound System (2007), 800 descendants of its own
- K093563: IU22 Ultrasound System and Transducers (2010), 588 descendants of its own

## Indications for use
The G20 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. Diagnostic imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K042833
Methodology: https://510kreport.com/methodology