Aurora MRI System Modification

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

Full name

Modification to Aurora MRI System

510(k) Number

K073425 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Aurora

  Class II

  FDA 510(k) K032082 Active Cleared 30 Jul 2003

• Aurora Magnetic Resonance Diagnostic Device

  Class II

  FDA 510(k) K012154 Active Cleared 19 Sep 2001

• Modification to: Aurora

  Class II

  FDA 510(k) K052698 Active Cleared 8 Nov 2005

• Aurora MR-Guided Interventional System

  Class II

  FDA 510(k) K023686 Active Cleared 29 Jan 2003

• Aurora

  Class II

  FDA 510(k) K003651 Active Cleared 21 Feb 2001

• Modification To: Aurora

  Class II

  FDA 510(k) K032678 Active Cleared 24 Sep 2003

• What type of facility is this MRI system modification intended for, and what kind of imaging does it support?

  This modification is designed for use in radiology settings and is intended to enhance the existing Aurora MRI system. It supports specialized imaging applications while maintaining core MRI functionality, such as non-invasive physiological and clinical data acquisition—all without using ionizing radiation.

• Is this modification a single-use or reusable component, and what sterility measures are required?

  The modification is supplied as a reusable component that integrates into the original Aurora MRI system. No additional sterility measures are required beyond those already in place for the base Aurora MRI system, as it is not classified as a single-use or disposable component.

• How was this modification approved by the FDA, and what does that mean for its regulatory status?

  The modification was cleared as Substantially Equivalent (SESE) under an FDA 510(k) submission (K073425), meaning it was determined to have the same intended use and technological characteristics as a legally marketed device. This clearance does not imply any specific clinical indication but confirms compliance with FDA standards for MRI safety and functionality.

• Does this modification introduce any new safety considerations for MRI environments?

  The modification adheres to MRI safety standards, ensuring compatibility with existing radiology environments. Since it is integrated into the original Aurora MRI system, no additional safety protocols beyond those already established for the base system are required.