OASIS MRI System

• • Terminated Z-2479-2018 FDA Class II ·initiated 18 Jun 2018 ·on shared 510(k) K093044

  The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K093044 ↗

FDA Product Code

LNI

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Hitachi Medical Systems America, Inc. →

• What types of medical imaging can the OASIS MRI System perform, and why is it specifically designed for clinical radiology settings?

  The OASIS MRI System is designed to generate detailed anatomical and functional images of the body using magnetic resonance imaging (MRI) and spectroscopic imaging techniques. It employs a vertical field magnet and advanced RF technology to create high-resolution scans, which are essential for diagnostic evaluations in radiology. Its specialized design ensures compatibility with MRI-safe environments, making it suitable for clinical radiology departments where precise imaging is required for patient assessment.

• Is the OASIS MRI System intended for single-use or reusable applications, and what maintenance does it require?

  The OASIS MRI System is not single-use—it is classified as a reusable medical device. Since it operates within clinical radiology settings, it requires regular maintenance, calibration, and servicing to ensure optimal performance and safety. The manufacturer provides guidelines for proper handling, storage, and upkeep to maintain compliance with regulatory standards and device functionality.

• How was the OASIS MRI System evaluated for regulatory approval, and what does the 'Radiology Advisory Committee' designation mean in this context?

  The OASIS MRI System underwent evaluation through the FDA 510(k) clearance process, specifically under the Radiology Advisory Committee (RA). This designation indicates that the device was reviewed by the FDA’s Radiology panel to determine substantial equivalence to a predicate device already on the market. The committee assessed its safety and effectiveness for use in magnetic resonance imaging (MRI) applications, ensuring it meets regulatory standards for clinical radiology use.

• What are the key specifications or features that distinguish the OASIS MRI System from other MRI devices?

  The OASIS MRI System is distinguished by its vertical field magnet technology and advanced RF (radiofrequency) capabilities, which enable high-resolution anatomical and functional imaging. Unlike some MRI systems, it is explicitly designed for spectroscopic imaging, allowing for detailed analysis beyond standard anatomical scans. Its reusable nature and compliance with MRI-safe standards also set it apart for long-term clinical use in radiology departments.