# K993069: GE Diasonics Gateway and Gateway FX

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Sep 22, 1999 after 9 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 K951998 (1996). 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)
- K951998: Diasonics Masters Series 5000 Ultrasound Scanner, Diasonics Ultrasound (1996) Summary page 1.
- K961002: Diasonics Itnraoperative Probes, Diasonics Ultrasound (1997) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K993069
Methodology: https://510kreport.com/methodology