# K080049: Vascuview Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Escalon Medical Corp.
- Decided: Jan 23, 2008 after 15 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: 3 generations back to K850478 (1985). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070907: Interson Usb Ultrasound Probe System, Regulatory Management Services (2007) Summary page 2.
- K021628: Sonosite Hand-Caried Untrasound System (Powerseries), Sonosite,Inc. (2002) Summary page 1.

## Indications for use
The VascuView ultrasound system provides ultrasound imaging of peripheral vascular structures in order to provide for ultrasound guidance for placement of needles and catheters in these structures. The VascuView ultrasound system is not intended for fetal or ophthalmic applications.

Source page: https://510kreport.com/device/K080049
Methodology: https://510kreport.com/methodology