# K040502: Sonoline Ebisu Diagnostic Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 9, 2004 after 11 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: 3 generations back to K933202 (1994). 7 ancestors in all.
930 later devices descend from it; 3 cite it directly.
2 of 938 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.
- K946179: Siemens Sonoline 4XX, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.
- K991611: GE Logiq 500, General Electric Co. (1999) Summary page 2.

## Most influential descendants
- K042833: Sonoline G20 Diagnostic Ultrasound Systems (2004), 928 descendants of its own
- K043016: Sonoline Orchid Diagnostic Ultrasound System (2004), 927 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K040502
Methodology: https://510kreport.com/methodology