# K974308: Medrad 1.5T Peripheral Vascular Array

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Jan 27, 1998 after 71 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GE Signa 1.5T Body Coil: named in the summary without a submission number

## Indications for use
The Peripheral Vascular Array is a phased array device which operates in the receive-only mode. The device is intended to receive signal from hydrogen protons during MR imaging. The Peripheral Vascular Array, as with any surface coil utilized in MR imaging, is intended to provide improved image quality as a result of the high Signal to Noise ratio (SNR) produced when placing a surface coil close to the anatomy of interest. Higher SNR allows the user to prescribe thinner slices and higher matrices necessary for the high spatial resolution needed in making diagnosis. The Peripheral Vascular Array is primarily designed for imaging of the vascular structures of the abdomen, pelvis, and lower limbs. Soft tissue imaging of these areas may also be evaluated using this device. The design of this coil allows the user to easily image the large peripheral vascular system associated with the abdomen, pelvis and lower limbs without moving the patient of the coil. Patient fitness and suitability to undergo an MRI exam utilizing the Peripheral Vascular Array must be determined by the individual physician trained in the field of Diagnostic Magnetic Resonance Imaging.

Source page: https://510kreport.com/device/K974308
Methodology: https://510kreport.com/methodology