510(k) K243428

e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector by Dxtx Medical, Inc. — Product Code MOS

K243428 is an FDA 510(k) premarket notification submitted by Dxtx Medical, Inc. for the device "e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector". The FDA issued a decision of Substantially Equivalent on July 17, 2025. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Dxtx Medical, Inc. has at least 1 other 510(k) clearance on record.