# K061637: Echoview/ Shimasonic Diagnostic Ultrasound System, Model Sdu-2200PRO

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Medical Systems
- Decided: Jul 25, 2006 after 43 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: 1 generation back to K003514 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003514: Echo View/Shimasonic Diagnostic Ultrasound System, Model Sdu-2200, Shimadzu Medical Systems (2001) Summary page 1.

## Most influential descendants
- K071287: Echoview / Shimasonic Diagnostic Ultrasound Device, Model Sdu-2200PRO (2008), 0 descendants of its own

## Indications for use
Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional.

Source page: https://510kreport.com/device/K061637
Methodology: https://510kreport.com/methodology