Magnetic Resonance Diagnostic Accessory

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

510(k) Number

K940364 ↗

FDA Product Code

LNH

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 Medical Advances, Inc. →

• What is the Magnetic Resonance Diagnostic Accessory used for?

  This device is a system intended for use in nuclear magnetic resonance imaging procedures, as defined by its device name and classification, and is used in radiology settings as part of MRI systems.

• How was the Magnetic Resonance Diagnostic Accessory cleared for market?

  The accessory was cleared via the FDA 510(k) pathway under K940364, with a traditional clearance decision and classification as a Class II device, based on a determination of substantial equivalence.

• Who manufactures the Magnetic Resonance Diagnostic Accessory and where are they located?

  The device is manufactured by Medical Advances, Inc., located at 10431 W. Watertown Plank Rd., P.O. Box 26425, Milwaukee, WI, United States.