# K904017: Siemens Sonoline SI-450, OB/Gyn,Ent,Dental Devices

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Ultrasound, Inc.
- Decided: Mar 21, 1991 after 203 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.
98 later devices descend from it; 1 cites it directly.
0 of 99 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
- K060992: Syngo US Workplace (2006), 97 descendants of its own
- K091286: Syngo US Workplace (2009), 95 descendants of its own
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own
- K132165: Qlab Quantification Software (2013), 91 descendants of its own
- K171314: QLAB Advanced Quantification Software (2017), 45 descendants of its own

Source page: https://510kreport.com/device/K904017
Methodology: https://510kreport.com/methodology