AU5 Ultrasound Imaging System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K000931 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

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. →

• What types of medical evaluations can the AU5 Ultrasound Imaging System assist with based on its intended use?

  The AU5 Ultrasound Imaging System is designed to generate real-time images of internal body structures using ultrasound technology. Based on its description, it supports evaluations of cardiac, abdominal, peripheral vessel, and fetal anatomy, making it versatile for general diagnostic imaging in clinical settings.

• Is the AU5 Ultrasound Imaging System intended for single-use or reusable applications?

  The AU5 Ultrasound Imaging System is explicitly described as a reusable medical device, meaning it is meant to be used multiple times after appropriate cleaning, maintenance, and sterilization procedures (if required). This distinguishes it from single-use devices.

• How was the AU5 Ultrasound Imaging System approved by the FDA, and what does that mean for its use?

  The AU5 received FDA 510(k) clearance under the product code IYN, with a decision of *Substantially Equivalent* to a previously cleared device. This means the FDA determined it has the same intended use and technological characteristics as a predicate device, allowing it to be marketed legally in the U.S. for its described diagnostic applications.

• What does the advisory committee classification (Radiology) imply about the AU5 Ultrasound Imaging System’s regulatory review?

  The Radiology advisory committee classification indicates that the device’s review was handled by the FDA’s Radiological Health Branch, which oversees imaging technologies. This committee provides expert input on safety, performance, and clinical relevance—though the classification itself doesn’t alter the device’s intended use or approval status.

• Does the AU5 Ultrasound Imaging System come with any pre-packaged accessories or consumables, or is it a standalone unit?

  The provided data does not specify included accessories or consumables, so the AU5 appears to be a standalone imaging system. Clinicians would likely need to procure probes, gels, and other consumables separately, depending on their imaging protocols.