# K110920: UF-760AG

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi Co., Ltd.
- Decided: Apr 8, 2011 after 7 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: 3 generations back to K003525 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081919: UF-870 AG Diagnostic Ultrasound System, Fukuda Denshi Co., Ltd. (2008) Summary page 1.
- K003525: Voluson 730 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.
- K032620: GE Voluson 730 Pro/Expert BT03 Ultrasound System, General Electric Co. (2003) Summary page 1.
- K041688: GE Voluson 730 Pro/Expert Untrasound BT04, General Electric Co. (2004) Summary page 1.

## Most influential descendants
- K131973: Unexef-38G Ultrasound System (2014), 0 descendants of its own

## Indications for use
The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Fetal/Obstetric, Gynecological, Abdominal (renal, Gyn/Pelvic), Small Organ (thyroid, breast, testes, etc.), Adult Cephalic, Trans-vaginal, Trans-cranial, Musculoskeletal (conventional &superficial), Card iac-AdultlPediatric/Fetal, Transesophageal (Cardiac), Peripheral vascular. The UF-760AG ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode, 3D14D, harmonic imaging), lime motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Power Doppler, Doppler Tissue Imaging, Color Flow Mapping (CFM) and Color lime Motion (CM)

Source page: https://510kreport.com/device/K110920
Methodology: https://510kreport.com/methodology