Ascent3T Neonatal Magnetic Resonance Imaging System

The Ascent3T is a 3.0 Tesla whole-body magnetic resonance imaging (MRI) system designed specifically for neonates and infants weighing up to 9 kg (19.8 lbs). It produces cross-sectional images of the head, body, and extremities in multiple orientations to aid in diagnosis when interpreted by a trained physician.

The Ascent3T features a 3.0 Tesla superconducting magnet with a 25 cm patient bore, 80 mT/m maximum gradient amplitude per axis with 300 mT/m/ms slew rate, minimal helium capacity (≤2L) with no quench pipe, real-time SAR monitoring with Normal and First-Level Controlled Operating Modes, and a detachable mobile patient table. This represents a higher field strength (3.0T vs. 1.0T) and larger bore than the predicate Embrace device.

Performance testing cited NEMA MS 1, MS 2, MS 3, MS 5, and MS 12 for imaging parameters; NEMA MS 4 and MS 8 for acoustic noise and SAR characterization. Safety and electromagnetic compatibility were demonstrated using IEC 60601-1-2, IEC TS 60601-4-2, ANSI AAMI ES60601-1, IEC 60601-1-6, and IEC 60601-2-33 standards via FDA's ASCA program.

The Ascent3T is substantially equivalent to the Embrace Neonatal MRI System (K170978) because both are neonatal-specific MRI devices with comparable intended uses, and all identified technological differences (higher field strength, larger bore, enhanced gradient performance) have been mitigated through rigorous design controls, risk analysis, and comprehensive performance testing. No new safety or effectiveness questions are raised.