# K984203: Siui Apogee 800PLUS Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instuments
- Decided: Nov 1, 1999 after 342 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 K903603 (1991). 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)
- K903603: Ultramark 9 Ultrasound System (UM 9), Advanced Technology Laboratories, Inc. (1991) Summary page 1.
- K924231: Interspec Apogee Cla, Interspec, Inc. (1993) Summary page 1.

## Indications for use
Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.

Source page: https://510kreport.com/device/K984203
Methodology: https://510kreport.com/methodology