# K980468: AU5 Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: Aug 26, 1998 after 201 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944485 (1995). 1 ancestor in all.
85 later devices descend from it; 5 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944485: 4000 AU Ultrasound Imaging System, Biosound, Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K023255: Technos MP, Model AU6 (2003), 66 descendants of its own

## Indications for use
The AUS ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.

Source page: https://510kreport.com/device/K980468
Methodology: https://510kreport.com/methodology