# K963065: CTS-285 with Ezu-PL21 and Ezu-PC3B Transducers

- 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 K862867 (1987). 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)
- K862867: Eub-310 Ultrasonic Scanner, Hitachi Medical Corp. of America (1987) Summary page 1.

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

Source page: https://510kreport.com/device/K963065
Methodology: https://510kreport.com/methodology