# K052894: Sonoline G60 S Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 23, 2005 after 40 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K935595 (1995). 34 ancestors in all.
926 later devices descend from it; 3 cite it directly.
2 of 961 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K042833: Sonoline G20 Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K043016: Sonoline Orchid Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K050240: Modification to Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own

## Recalls of this device
- Aug 5, 2008 · Not classified · Z-2468-2008: As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.

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

Source page: https://510kreport.com/device/K052894
Methodology: https://510kreport.com/methodology