# K050034: Sonoline Antares Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 13, 2005 after 6 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: 5 generations back to K935595 (1995). 20 ancestors in all.
921 later devices descend from it; 6 cite it directly.
2 of 942 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001400: Elegra Millennium Enhanced Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Recalls of this device
- Mar 1, 2010 · Not classified · Z-1853-2011: Image captured from the device may be erroneous.

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

Source page: https://510kreport.com/device/K050034
Methodology: https://510kreport.com/methodology