# K043016: Sonoline Orchid Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 16, 2004 after 14 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: 5 generations back to K935595 (1995). 25 ancestors in all.
927 later devices descend from it; 2 cite it directly.
2 of 953 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033196: Sonoline Antares with Clarify VE, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K040502: Sonoline Ebisu Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## 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
Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows: Diagnostic imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K043016
Methodology: https://510kreport.com/methodology