# K981404: Fukuda Denshi Ultrasound Scanners Models UF-3500 and UF-4500

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: May 20, 1998 after 33 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 K933202 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 1.
- K970901: GE Logiq 500 Diagnostic Ultrasound System, GE Medical Systems (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 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/K981404
Methodology: https://510kreport.com/methodology