# K161342: Sonic Window

- Pathway: 510(k) (Special)
- Applicant: Analogic Corporation
- Decided: Jun 15, 2016 after 33 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: 5 generations back to K000567 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140126: Sonic Window, Analogic Corporation (2014) Summary page 5.

## Indications for use
The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. Diagnostic ultrasound imaging and visualization of vessels for vascular access guidance of needles and catheters as follows:

Source page: https://510kreport.com/device/K161342
Methodology: https://510kreport.com/methodology