# K955543: Ultrasound System Model UF-3500

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Feb 11, 1997 after 434 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 K922208 (1993). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- 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

## Indications for use
This device is intended to be used for applications in fetal, abdominal, intra-operative, pediatric, small organ, trans-rectal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either transrectally or intraoperatively. It is intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-3500 is intended to be used in a doctors office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.

Source page: https://510kreport.com/device/K955543
Methodology: https://510kreport.com/methodology