AU5, AU6

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K000681 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Galileo Halley

  Class II

  FDA 510(k) K970703 Active Cleared 19 May 1997

• AU5 Ultrasound Imaging System

  Class II

  FDA 510(k) K980468 Active Cleared 26 Aug 1998

• Modification to Artoscan M

  Class II

  FDA 510(k) K010057 Active Cleared 2 Feb 2001

• Archimed 4210 and 4220

  Not classified

  FDA 510(k) K973922 Active Cleared 12 May 1998

• 7250 Ultrasound Imaging System

  Class II

  FDA 510(k) K982444 Active Cleared 6 Oct 1998

• AU6

  Class II

  FDA 510(k) K990360 Active Cleared 30 Apr 1999

See all devices from Biosound Esaote, Inc. →