# K092182: Voyager Compact Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ardent Sound, Inc.
- Decided: Oct 9, 2009 after 80 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 K944287 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020112: 50S Tringa Ultrasound Imaging System, Pie Medical (2002) Summary page 2.
- K980468: AU5 Ultrasound Imaging System, Biosound Esaote, Inc. (1998) Summary page 2.
- K000681: AU5, AU6, Biosound Esaote, Inc. (2000) Summary page 2.

## Indications for use
The intended uses of this system and its accessories are as follows: Evaluating Soft Tissue by Ultrasound Imaging, using B-mode and M-mode: For Fetal, Abdominal, 3D Visualization (non-measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel, Transvaginal, Transrectal and Needle Guidance.

Source page: https://510kreport.com/device/K092182
Methodology: https://510kreport.com/methodology