# K990360: AU6

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: Apr 30, 1999 after 84 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: 2 generations back to K944485 (1995). 2 ancestors in all.
83 later devices descend from it; 4 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980468: AU5 Ultrasound Imaging System, Biosound Esaote, Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K051837: Mylab 90 Ultrasound Imaging System, Model 6100 (2005), 64 descendants of its own

## Indications for use
The AU6 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/K990360
Methodology: https://510kreport.com/methodology