# K050551: Voyager Personal Imaging Device

- Pathway: 510(k) (Traditional)
- Applicant: Ardent Sound, Inc.
- Decided: Mar 22, 2005 after 19 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: 4 generations back to K944485 (1995). 5 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013142: Diasus, Dynamic Imaging, Ltd. (2001) Summary page 1.
- K980468: AU5 Ultrasound Imaging System, Biosound Esaote, Inc. (1998) Summary page 1.
- K000681: AU5, AU6, Biosound Esaote, Inc. (2000) Summary page 1.

## Most influential descendants
- K132736: Accuro 3000 Ultrasound Scanner (2014), 5 descendants of its own
- K171594: Accuro (2017), 3 descendants of its own
- K243937: Accuro 3S (2025), 2 descendants of its own
- K102253: Echo Blaster (2011), 1 descendant of its own
- K253452: Accuro 3S (2026), 0 descendants of its own

## Indications for use
Imaging: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ (thyroid and breast). Musculoskeletal (Conventional), Peripheral Vessel and Needle Guidance.

Source page: https://510kreport.com/device/K050551
Methodology: https://510kreport.com/methodology