Inkspace Imaging, Inc. · Class II · Cleared Oct 20, 2025
| K-number | K253182 |
| Device name | InkSpace Imaging Small Body Array (SBA12PH30x) |
| Applicant | Inkspace Imaging, Inc. |
| Product code | MOS |
| Device class | Class II |
| Decision date | Oct 20, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1000 |
The InkSpace Imaging Small Body Array (SBA12PH30x) is a receive-only coil designed for use with Philips 3.0 Tesla MRI scanners. It consists of 12 lightweight, flexible elements enclosed in a soft padded pouch, optimized to conform to patient anatomy while providing high signal-to-noise ratio for diagnostic imaging of cardiac, hip, shoulder, liver, knee, and ankle regions.
The device is a 12-element phased array coil modified to operate with Philips 3.0T MRI systems at 127.73MHz, differing from the predicate device which was designed for Siemens scanners. Philips systems support only a single 12-channel pad configuration. Changes are limited to non-substantive modifications for clarity and updated documentation; the functional design and performance specifications remain substantially equivalent.
Performance testing was conducted per FDA Guidance Document 'Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway' (December 11, 2020). Testing included signal-to-noise ratio, image uniformity, surface heating, decoupling circuit, EMC immunity, electrostatic discharge, general electrical/mechanical safety, acquired image quality, and transit testing.
View the full FDA submission: accessdata.fda.gov