# K003125: Sonoline Elegra Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 20, 2000 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
No predicates in its family tree.
951 later devices descend from it; 1 cites it directly.
2 of 952 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040060: Sonoline G50 and G60 S Diagnostic Ultrasound Systems (2004), 950 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
- 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

Source page: https://510kreport.com/device/K003125
Methodology: https://510kreport.com/methodology