# K061641: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sarano

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Jul 14, 2006 after 32 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: 4 generations back to K933202 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050510: Echoview/Shimasonic Diagnostic Ultrasound System, Model Sdu-1100, Shimadzu Medical Systems (2005)

## Most influential descendants
- K082224: Diagnostic Ultrasound System Sarano, Echo View, Shimasonic (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/K061641
Methodology: https://510kreport.com/methodology