# K071289: Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PRO

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Jan 9, 2008 after 246 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003514 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061643: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PRO, Shimadzu Medical Systems (2006) Summary page 1.

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

Source page: https://510kreport.com/device/K071289
Methodology: https://510kreport.com/methodology