# K922208: Fukuda Denshi Model UF-4500

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Aug 30, 1993 after 475 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
No predicates in its family tree.
6 later devices descend from it; 3 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K955543: Ultrasound System Model UF-3500 (1997), 4 descendants of its own
- K990401: Fukuda Denshi FF Sonic UF-5800 General Purpose Ultrasound Scanning System with Doppler (1999), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K922208
Methodology: https://510kreport.com/methodology