# K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 28, 2004 after 15 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: 4 generations back to K935595 (1995). 18 ancestors in all.
950 later devices descend from it; 6 cite it directly.
2 of 969 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020353: Omnia X/XS Ultrasound System, Siemens Medical Systems, Inc. (2002) Summary page 1.
- K032111: Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K003525: Voluson 730 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.
- K003125: Sonoline Elegra Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.

## Most influential descendants
- K043016: Sonoline Orchid Diagnostic Ultrasound System (2004), 927 descendants of its own
- K052894: Sonoline G60 S Ultrasound System (2005), 926 descendants of its own
- K050034: Sonoline Antares Diagnostic Ultrasound System (2005), 921 descendants of its own
- K052021: V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer (2005), 806 descendants of its own
- K063138: Modification to Acuson Antares Ultrasound System (2006), 802 descendants of its own

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

Source page: https://510kreport.com/device/K040060
Methodology: https://510kreport.com/methodology