# K081919: UF-870 AG Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Fukuda Denshi Co., Ltd.
- Decided: Sep 9, 2008 after 64 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K002239 (2000). 4 ancestors in all.
2 later devices descend from it; 2 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)
- K050099: Sigma 5000 Series Imagic Ultrasound System, Kontron Medical Systems Sas (2005) Summary page 1.
- K053084: Sigma 5000 Series Imagic Ultrasound System, Kontron Medical Systems Sas (2005) Summary page 1.
- K061437: Sigma 5000 Series, Imagic, Kontron Medical Systems Sas (2006) Summary page 1.

## Most influential descendants
- K110920: UF-760AG (2011), 1 descendant of its own
- K131973: Unexef-38G Ultrasound System (2014), 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/K081919
Methodology: https://510kreport.com/methodology