InkSpace Imaging Small Body Array
InkSpace Imaging, Inc.The InkSpace Imaging Small Body Array is a flexible, receive-only MRI coil designed for use with Siemens 1.5T MRI systems. It helps capture high-quality diagnostic images of various body parts such as the heart, spine, joints, and prostate, assisting physicians and radiologists in making accurate diagnoses. The coil's flexible design improves patient comfort and scanning convenience.
Intended Use
The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 1.5T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.
Technology
The coil is a 24-channel phased array receive-only coil consisting of two flexible pads each with 12 coil elements designed to conform to patient anatomy. It operates with Siemens 1.5T MRI scanners at a frequency of 63.6 MHz. The device uses soft, pliable materials for enhanced patient comfort and is reusable and non-sterile.
Performance
Nonclinical bench tests verified image signal-to-noise ratio, image uniformity, surface heating, decoupling circuits, electromagnetic immunity, electrical and mechanical safety, and acquired image quality. Risk analyses leveraged prior tests from a similar 3.0T device. Clinical images reviewed by a board-certified radiologist demonstrate comparable diagnostic quality. The results show the device is safe and effective for MR imaging with Siemens 1.5T systems.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/27/2024
23 days - 2
FDA Approval
12/20/2024
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