Model 675GE-64 Peripheral Vascular Coil Consisting of Model 665GE-64: Lower Extremity Flexible Array and Model 538GE-64:

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

510(k) Number

K964813 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Phased Array Shoulder Coil, Quadrature Shoulder Coil

  Class II

  FDA 510(k) K945778 Active Cleared 23 Mar 1995

• Multi Purpose Flex Array Coil : Model 235 Series

  Class II

  FDA 510(k) K000345 Active Cleared 11 Apr 2000

• Model 475 - 8 Channel T/R Phased Array Lower Extremity Coil

  Class II

  FDA 510(k) K040640 Active Cleared 22 Mar 2004

• Model 600GE-64: Bilateral Breast Coil

  Class II

  FDA 510(k) K930122 Active Cleared 26 Jul 1993

• Model 455GE Phased Array Wrist Coil

  Class II

  FDA 510(k) K010074 Active Cleared 3 Apr 2001

• Magnetic Resonance Diagnostic Accessory

  Class II

  FDA 510(k) K940364 Active Cleared 21 Jun 1994

See all devices from Medical Advances, Inc. →

• What is the Model 675GE-64 Peripheral Vascular Coil used for?

  The Model 675GE-64 Peripheral Vascular Coil is designed specifically for Magnetic Resonance (MRI) imaging of peripheral vascular structures. It consists of a flexible array coil (Model 665GE-64) and a dedicated coil (Model 538GE-64) tailored to enhance signal reception in blood vessels of the lower extremities, such as the legs and feet. This improves the clarity and detail of vascular imaging, aiding in the diagnosis of conditions like peripheral artery disease.

• Is the Model 675GE-64 coil reusable or single-use?

  The Model 675GE-64 Peripheral Vascular Coil is supplied as a reusable device. It is not intended for single-use applications. Reusability is suitable for clinical environments where proper cleaning, maintenance, and storage protocols are followed to ensure consistent performance and patient safety.

• What are the key storage requirements for this MRI coil?

  The Model 675GE-64 coil must be stored in a way that protects it from electromagnetic interference and physical damage. Since it is designed for MRI-compatible environments, it should be kept in a location free from strong magnetic fields or sources of interference that could compromise its functionality. Adherence to standard MRI coil maintenance protocols is essential to preserve its performance and longevity.

• What regulatory status does the Model 675GE-64 hold?

  The Model 675GE-64 Peripheral Vascular Coil holds a FDA 510K clearance (K964813) with a Substantially Equivalent determination by the Radiology Advisory Committee. It is classified as a Class II medical device under 21 CFR 892.1000, indicating it has undergone regulatory review for safety and effectiveness in its intended use.

• How does the flexible array design benefit lower extremity imaging?

  The flexible array coil (Model 665GE-64) in the Model 675GE-64 is engineered to conform closely to the contours of the lower extremities. This design reduces signal loss and improves uniformity of magnetic field reception across the vascular structures, resulting in higher-resolution images of blood vessels in the legs and feet. The dedicated coil (Model 538GE-64) further optimizes signal clarity for targeted vascular imaging.