# K050510: Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Apr 1, 2005 after 31 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: 3 generations back to K933202 (1994). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991611: GE Logiq 500, General Electric Co. (1999) Summary page 1.

## Most influential descendants
- K061641: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sarano (2006), 1 descendant of its own
- K082224: Diagnostic Ultrasound System Sarano, Echo View, Shimasonic (2008), 0 descendants of its own
- K071291: Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1100 (2008), 0 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:

Source page: https://510kreport.com/device/K050510
Methodology: https://510kreport.com/methodology