Sonix Ultrasound Scanner

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K061827 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Sonixgps Needle Sensor

  Class II

  FDA 510(k) K111818 Active Cleared 13 Jun 2012

• Sonixgps Vascular Access Needle Kit

  Class II

  FDA 510(k) K120349 Active Cleared 9 Apr 2012

• Sonix Ultrasound Scanner

  Class II

  FDA 510(k) K093462 Active Cleared 20 Nov 2009

• Sonixtablet Ultrasound Scanner

  Class II

  FDA 510(k) K102997 Active Cleared 21 Dec 2010

• Sonix Mdp Ultrasound Scanner

  Class II

  FDA 510(k) K080935 Active Cleared 6 Aug 2008

• Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner

  Class II

  FDA 510(k) K042326 Active Cleared 16 Sep 2004

See all devices from Ultrasonix Medical Corporation →

• What is the Sonix Ultrasound Scanner used for?

  The Sonix Ultrasound Scanner is a diagnostic ultrasound imaging system intended for use in radiology settings. It features customizable touch screens to simplify workflows and is built on an open software platform that enables remote service and easy updates to keep current with advancements in imaging technology.

• How is the Sonix Ultrasound Scanner supplied and what are its storage requirements?

  The Sonix Ultrasound Scanner is supplied as a medical device that requires appropriate storage and handling according to manufacturer guidelines. It should be stored in a clean, dry environment as specified in the provided user manual to maintain optimal performance and longevity.

• What is the regulatory status of the Sonix Ultrasound Scanner?

  The Sonix Ultrasound Scanner has FDA 510(k) clearance (K061827) and is classified under product code IYN. It was determined to be substantially equivalent through a traditional review process by the Radiology advisory committee.

• Who should operate the Sonix Ultrasound Scanner?

  The Sonix Ultrasound Scanner is designed to be operated by trained medical professionals following the provided user manual instructions. Proper training is essential to ensure safe and effective use of the device for diagnostic imaging purposes.