# K944485: 4000 AU Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Biosound, Inc.
- Decided: May 24, 1995 after 253 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
No predicates in its family tree.
87 later devices descend from it; 3 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980468: AU5 Ultrasound Imaging System (1998), 85 descendants of its own
- K990360: AU6 (1999), 83 descendants of its own
- K014168: AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal Indication) (2002), 71 descendants of its own
- K040596: Ultrasound Imaging System, Model 7300 (2004), 67 descendants of its own
- K050326: 7350 Ultrasound Imaging System, Model 7350 (2005), 66 descendants of its own

Source page: https://510kreport.com/device/K944485
Methodology: https://510kreport.com/methodology