# K242662: Falcon/Xpress (Falcon/Xpress)

- Pathway: 510(k) (Traditional)
- Applicant: Viasonix, Ltd.
- Decided: Dec 18, 2024 after 105 days
- Product code: JOP (Transducer, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 870.2880
- 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 K904392 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111416: Falcon, Viasonix, Ltd. (2011) Summary page 5.

## Indications for use
The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. The Falcon/Xpress is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. The Falcon/Xpress is to be used only by trained medical personnel in hospitals, clinics and physicians’ offices by prescription or doctor’s orders

Source page: https://510kreport.com/device/K242662
Methodology: https://510kreport.com/methodology