# K990401: Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with Doppler

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Oct 15, 1999 after 248 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: 2 generations back to K922208 (1993). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922208: Fukuda Denshi Model UF-4500, Fukuda Denshi USA, Inc. (1993) Summary page 1.
- K955543: Ultrasound System Model UF-3500, Fukuda Denshi USA, Inc. (1997) Summary page 1.
- K925582: Medison 4800, Medison America, Inc. (1994) Summary page 1.

## Most influential descendants
- K033209: Fukuda Denshi Model FF Sonic UF-750XT (2003), 2 descendants of its own
- K082656: Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging Unit (2008), 0 descendants of its own
- K050363: Fukuda Denshi Model UF-850XTD (2005), 0 descendants of its own

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

Source page: https://510kreport.com/device/K990401
Methodology: https://510kreport.com/methodology