InkSpace Imaging Small Body Array

The InkSpace Imaging Small Body Array is a receive-only MRI coil with 24 channels (two 12-channel flexible pads) designed for use with Siemens 1.5T magnetic resonance imaging systems. It is used to obtain diagnostic images of general human anatomy including cardiac, spine, shoulder, elbow, knee, foot, and prostate in adult and pediatric patients, with images interpreted by trained physicians to assist in diagnosis.

The subject device is a 24-channel receive-only phased array operating at 63.6 MHz (hydrogen frequency for 1.5T), composed of two identical flexible 12-channel pads made of soft, pliable materials. It is reusable, non-sterile, and prescription-only. The predicate operates at 123.2 MHz for 3.0T systems but shares identical construction, channel count, materials, and physical design; the only difference is the receiver frequency due to different MRI field strength.

Performance testing was conducted per the FDA Guidance Document 'Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway' (December 11, 2020). Biocompatibility testing followed ISO 10993 standards.

The 1.5T device maintains the same intended use, indications, patient populations, and physical design as the 3.0T predicate, differing only in receiver frequency (63.6 MHz vs. 123.2 MHz), which is a fully-verified and expected consequence of operation at a different magnetic field strength with the same OEM (Siemens). Nonclinical bench testing on the 1.5T device and risk-based acceptance of predicate testing for biocompatibility, usability, and transit demonstrate no new or different safety or effectiveness questions; the materials, manufacturing, and design meet established specifications for consistent performance.