# K050363: Fukuda Denshi Model UF-850XTD

- Pathway: 510(k) (Special)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Feb 17, 2005 after 3 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922208 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033209: Fukuda Denshi Model FF Sonic UF-750XT, Fukuda Denshi USA, Inc. (2003) Summary page 3.

## Indications for use
The device is intended to be used for applications in fetal, abdominal, pediatric, small organ (defined as the thyroid, breast and testes), cardiac (adult and pediatric), transvaginal, peripheral vessel and musculo-skeletal (Conventional and Superficial). The UF-85OXTD incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-85OXTD is a prescription device intended to be use by or on the order of a physician or similarly qualified healthcare professional. The device is intended to be used 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/K050363
Methodology: https://510kreport.com/methodology