# K963068: CTS-200 with Ezu-PL21 Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instuments
- Decided: May 29, 1997 after 295 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: 1 generation back to K862164 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862164: Eup-012I, Eup-012J & Eub-0124 Ultrasonic Scanner, Hitachi Medical Corp. of America (1986) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging of the human body as follows: Fetal Abdominal Cardiac Adult

Source page: https://510kreport.com/device/K963068
Methodology: https://510kreport.com/methodology