# K003514: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-2200

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Feb 12, 2001 after 90 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K061643: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PRO (2006), 1 descendant of its own
- K061637: Echoview/ Shimasonic Diagnostic Ultrasound System, Model Sdu-2200PRO (2006), 1 descendant of its own
- K071287: Echoview / Shimasonic Diagnostic Ultrasound Device, Model Sdu-2200PRO (2008), 0 descendants of its own
- K071289: Echoview / Shimasonic Diagnostic Ultrasound System, Model Sdu-1200PRO (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K003514
Methodology: https://510kreport.com/methodology