Medrad Neurovascular Coil

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

510(k) Number

K981094 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Mriinnervu Disposable Endorectal Cervic Coil, Catalog No. Bcr-15

  Class II

  FDA 510(k) K952235 Active Cleared 26 Jun 1995

• Medrad Phased Array 1.5T Shoulder Imaging Surface Coil

  Class II

  FDA 510(k) K960901 Active Cleared 29 May 1996

• Benzalkonium-Heparin Coated Guidewires

  Class II

  FDA 510(k) K802473 Active Cleared 12 Nov 1980

• Medrad Counterpoise System

  Class II

  FDA 510(k) K944983 Active Cleared 29 Nov 1994

• Medrad Fluoroscopic Video Enhancement System

  Class II

  FDA 510(k) K884317 Active Cleared 20 Dec 1988

• Mrinnervu Endorectal Prostate Coil

  Class II

  FDA 510(k) K925029 Active Cleared 19 May 1993

See all devices from Medrad, Inc. →

• What is the Medrad Neurovascular Coil used for?

  The Medrad Neurovascular Coil is designed specifically for neurovascular MRI applications. It improves signal reception and contrast in critical regions such as the brain, skull base, and soft tissues of the neck and upper chest, including the carotid arteries and associated vascular structures. This enhances diagnostic accuracy for imaging these areas.

• How is the Medrad Neurovascular Coil supplied, and what configurations are available?

  The Medrad Neurovascular Coil is supplied in multiple configurations, each identified by unique FEI numbers. These configurations cater to different MRI setups and imaging requirements. Examples of FEI numbers include 3009529630, 3027339477, and several others listed in the device specifications. The coil must be used in MRI-compatible environments and adheres to MRI safety protocols.

• Is the Medrad Neurovascular Coil single-use or reusable?

  The Medrad Neurovascular Coil is not explicitly described as single-use or reusable in the provided data. However, coils of this type are typically reusable if properly cleaned, sterilized, and maintained according to manufacturer guidelines. Always follow the manufacturer’s instructions for storage and handling to ensure performance and integrity.

• What safety considerations apply to the Medrad Neurovascular Coil?

  The Medrad Neurovascular Coil is classified as Class II and must be used in MRI-compatible environments. This means it must comply with MRI safety protocols to prevent interference or hazards during imaging. Proper storage and handling, as outlined by Medrad, are essential to maintain the coil’s performance and ensure safe use in clinical settings.

• How do I determine the correct configuration for my MRI system?

  The correct configuration for your MRI system depends on the specific imaging requirements and compatibility with your scanner. The coil is available in multiple configurations, each identified by unique FEI numbers. Consult your MRI system’s documentation or contact Medrad’s technical support to select the appropriate coil for your setup. Ensure the chosen configuration aligns with your imaging goals for neurovascular structures.