510(k) K213397

InkSpace Imaging Pediatric Body Array by Inkspace Imaging, Inc. — Product Code MOS

K213397 is an FDA 510(k) premarket notification submitted by Inkspace Imaging, Inc. for the device "InkSpace Imaging Pediatric Body Array". The FDA issued a decision of Substantially Equivalent on December 17, 2021. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Inkspace Imaging, Inc. has at least 4 other 510(k) clearances on record.